It is an important part of quality management in the pharmaceutical industry, as it helps to ensure the safety and quality of pharmaceutical products.

This article will discuss the definition of deviation, its different classification types and categorization, guidelines applicable to deviation management, and deviation management process flow. We will also explore the role of QMS software in effectively managing deviations.

SimplerQMS provides eQMS software tailored for pharmaceutical companies with robust deviation management capabilities. Schedule a demo today and talk to one of our quality consultants to get a more comprehensive understanding of our QMS software.

The following topics are further discussed in this article:

• What Is a Deviation?
• What Is Deviation Management?
• What Are the Different Classification Types of Deviation?
• How Are Deviations Categorized Based on Risk?
• What Are the Deviation Management Guidelines in the Pharmaceutical Industry?
• What Is a Deviation Management Process Flow?
• What Is the Role of Deviation Management Software in Streamlining the Deviation Management Process?

What Is a Deviation?

A deviation is any departure from approved processes, procedures, instructions, specifications, or established standards.

In the pharmaceutical industry, deviations can occur during drug product development, manufacturing, labeling, packing, sampling, testing, storage, distribution, and other processes.

The deviation definition can vary slightly depending on the regulatory authority and requirements governing the company’s processes.

Some definitions of deviations according to different regulatory organizations and requirements are as follows.

International Organization for Standardization (ISO):

According to ISO 9001:2015, deviations in the context of quality management systems refer to the positive or negative effect resulting from a divergence from the expected or established standards.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH):

In the ICH Q7 Good Manufacturing Practice (GMP) guide for active pharmaceutical ingredients, a deviation is defined as a departure from an approved instruction or an established standard.

Food and Drug Administration (FDA):

In the FDA’s guidance on quality management systems for the pharmaceutical industry and current Good Manufacturing Practice (cGMP) regulations, a deviation is described as a result that falls outside the expected range or fails to fulfill a specific requirement.

What Is Deviation Management?

Deviation management is the systematic process of identifying, assessing, and addressing any deviations that occur from approved instructions or established standards within a company.

The objective of deviation management in the pharmaceutical industry is to promptly identify, investigate, and resolve any deviations.

Deviation management is an essential QMS process in a Pharmaceutical Quality Management System.

By promptly identifying and addressing deviations, pharmaceutical companies can provide safe, uniform, high quality, and effective products to patients while maintaining their reputation in the market and compliance with regulatory requirements.

Effective deviation management plays a crucial role in handling diverse types of deviations, streamlining processes, and fostering continuous improvement.

What Are the Different Classification Types of Deviation?

There are two main classification types of deviations: planned and unplanned deviations.

Planned Deviation

Planned deviations refer to pre-approved and intentional deviations from standard procedures or processes.

These deviations are planned and justified in advance, serving various purposes, such as process improvement, method validation, and temporary process changes.

Some examples of planned deviations include:

• Implementing a temporary manufacturing process change to test and validate potential efficiency improvements.
• Using an alternative raw material as part of a trial to assess its suitability without affecting product quality.
• Temporarily adopting an alternative testing method to validate its accuracy and reliability compared to the standard method.

Change control and change requests are essential components of managing planned deviations in a controlled and systematic manner.

Change request documents are part of the change control process. They provide a formal and structured way to propose and justify the planned deviation, outlining its purpose, scope, and potential impact.

The change control process in the pharmaceutical industry ensures that relevant personnel can assess and approve the proposed change, considering its implications on product quality, safety, and regulatory compliance.

Implementing planned deviations through these processes helps maintain control, traceability, and well-structured documentation.

Unplanned Deviation

Unplanned deviations refer to a departure from approved procedures without prior notice or intention.

Various factors, such as equipment malfunction, employee error, environmental events, or others, can cause them.

Unplanned deviations can significantly impact product quality and safety, and such deviations should be investigated promptly to identify the root cause and prevent them from happening again.

Some examples of unplanned deviations include:

• The sudden breakdown of manufacturing equipment leads to deviations from standard operating conditions and affects product quality.
• Deviations are caused by unforeseen events like power outages, extreme weather conditions, or natural disasters that disrupt manufacturing.
• Accidental introduction of foreign materials into the production process, leading to material contamination and deviation from product specifications.

Companies employ Corrective and Preventive Action (CAPA) processes to effectively address and resolve unplanned deviations.

When an unplanned deviation occurs, the CAPA process is used to implement corrective actions, aiming to mitigate the immediate deviation impact. Afterward, preventive actions are developed to avoid the recurrence of similar deviations in the future.

The CAPA process implementation varies based on each specific company’s established procedures. Companies assess the severity and categorization of the deviation based on risk to determine whether the CAPA process will be initiated.

How Are Deviations Categorized Based on Risk?

Deviations are categorized based on risk levels to assess their potential impact on product quality, patient safety, and the regulatory requirements companies are subject to.

Companies can have different criteria for defining deviation categories, which are well-described in their protocols and procedures. The categorization of deviations may vary based on the nature of the product, industry requirements, and the company’s risk management needs.

The risk-based deviation categories usually include:

• Incidents
• Minor deviations
• Major deviations
• Critical deviations

Incident

An incident is an unplanned or uncontrolled event that does not directly affect the manufacturing process parameters or product quality.

Incidents are generally unrelated to GMP requirements and are often not considered deviations.

However, an incident affecting product specifications can be categorized as a cGMP-related nonconformance.

This categorization varies between companies and must be clearly specified in the company’s procedures.

Examples of incidents are listed below:

• Accidental material spillage occurred in the cleanroom.
• Personnel not appropriately dressed inside the production area.
• A minor typographical error in the documentation that does not affect the overall process or product outcome.

Minor

A minor deviation involves divergences from established procedures or standards that have a noticeable but limited impact on product quality or regulatory compliance.

Examples of minor deviations are listed below:

• A slight variation in the size or appearance of a product that does not affect its efficacy or safety.
• A deviation in the production timeline that leads to a slight delay but does not compromise the overall product quality.
• Documentation errors that do not compromise data integrity.

Major

A major deviation indicates a significant departure from established procedures or standards that can considerably impact pharmaceutical drug quality and regulatory requirements.

Examples of major deviations are presented below:

• A deviation in the manufacturing process results in an out-of-specification (OOS) product requiring investigation and corrective actions to prevent further occurrences.
• A failure of critical equipment during production leads to a significant delay in the manufacturing process and a potential impact on product quality.

Critical

A critical deviation denotes a severe nonconformance from established procedures or standards that poses meaningful risks to product quality, patient safety, or compliance with applicable requirements.

Examples of critical deviations are given below:

• Contamination of a critical raw material used in the production process that may lead to a serious health risk for patients.
• Issues in the packaging process that result in incorrect labeling or dosage instructions which can pose a high risk of incorrect medication intake and patient harm.
• The failure of the HEPA filters in the cleanroom that may lead to potential contamination risks and compromise the integrity of the controlled environment.

When an unexpected event occurs, pharmaceutical companies need to categorize the event to be able to follow the appropriate procedures to solve the issue.

An example of a decision pathway that can be used to categorize incidents and deviations is provided below.

The first step is to identify if the event has a significant impact on the manufacturing process parameters, SOPs, or cGMP. If the event does not have a significant impact, then the event is considered an incident.

However, it is considered a deviation if the event significantly impacts and affects a product attribute.

To determine the severity of the deviation, it is necessary to know if it affects the operations or critical parameters and equipment or instruments.

The deviation can be categorized as minor if none of those are affected. Otherwise, it can be considered a major or critical deviation.

The flowchart below illustrates the deviation categorization process.

What Are the Deviation Management Guidelines in the Pharmaceutical Industry?

Deviation management guidelines vary depending on the specific market that pharmaceutical companies operate in and their product.

The deviation management process must align with the applicable requirements and industry best practices.

In the pharmaceutical industry, various standards, regulations, and guidelines outline requirements regarding deviation management. Below are some of them.

ISO 9001:2015

The ISO 9001:2015 is a general quality management system standard that specifies requirements for quality systems in several industries. Some pharmaceutical companies choose to comply with ISO 9001:2015 standards.

The standard addresses deviation management in Section 10.2. When a deviation occurs, companies must react to the problem by taking control of the situation and investigating the root cause to correct the problem and manage its consequences.

Preventive actions should be implemented to avoid the recurrence of the deviation, considering similar issues. Companies need to keep records of the deviations, actions taken, and the results of corrective actions.

FDA 21 CFR Part 211

The 21 CFR Part 211 outlines the cGMP requirements for finished pharmaceuticals for companies in FDA-regulated industries.

According to 21 CFR 211.100, pharmaceutical companies must have written procedures for production and process control deviations.

Deviation documents should be drafted, reviewed, and approved by relevant departments and the quality control unit. Procedures must be followed during production, and any deviation from them must be recorded and justified to maintain product integrity and compliance.

ICH Q7

The ICH Q7 defines the GMP guidelines for active pharmaceutical ingredients (API).

Within ICH Q7 quality management guidelines, Section 2.16 emphasizes the importance of documenting and explaining any deviation from established procedures.

The quality documentation related to deviations ensures transparency and accountability in the manufacturing process, helping to maintain the quality, safety, and consistency of API production.

EU and PIC/S GMP Guide Part 1

In the Eudralex GMP and PIC/S GMP Guide Part I for medicinal products, Section 1.8 (vii) specifies that significant deviations from established procedures must be thoroughly recorded.

These deviations should be investigated comprehensively to identify the root cause. Based on the findings, appropriate corrective and preventive actions must be implemented to prevent similar deviations from occurring in the future.

(EU) No 1252/2014

The European Union regulation 1252/2014 sets forth the principles and guidelines of GMP for active substances for medicinal products.

It is established in Article 7 that during the manufacturing process, all quality-related activities, including deviation management processes, must be documented as they are performed. So, if any deviation occurs from the written procedures, it must be documented and explained.

Furthermore, if any deviations impact the quality of the active substance or prevent it from meeting the specifications, a thorough investigation must take place. The findings and conclusions of the investigation must be documented.

There are common requirements across all deviation management regulations, standards, and guidelines that outline the typical steps in the deviation management process.

What Is a Deviation Management Process Flow?

The deviation management process flow follows a systematic approach to identifying, reporting, investigating, documenting, correcting, and preventing deviations from approved or established standards. It outlines how to handle deviations in a structured and organized manner.

In this section, we will discuss the steps involved in the deviation management process and how QMS software like SimplerQMS streamlines each step.

The deviation management process flow typically follows the following steps:

1. Identification
2. Reporting
3. Investigation
4. Documentation
5. Implementation

Identification

The initial phase involves understanding the event that led to a deviation. Deviations can arise at any stage during the product manufacturing lifecycle.

As mentioned earlier, these events are classified as incident, minor, major, or critical, depending on their severity and potential impacts.

The correct categorization helps in prioritizing deviation resolution and determining the appropriate level of investigation and corrective actions required to address each type of deviation.

In SimplerQMS, categorizing deviation is a straightforward process.

Companies can create their own categories and select the relevant ones using dropdown menus when drafting deviation-related documents.

Reporting

The Deviation Report holds significant importance in the deviation management process. It is a formal document used to record and document each identified deviation.

The Deviation Report provides a comprehensive account of the deviation, including its nature, location, date, time, personnel involved, and potential impact on product quality or safety.

When a deviation occurs, the department responsible for the process where the deviation took place is usually responsible for filing the Deviation Report. Timeliness is essential in this phase, and the report should be filed within a specified timeframe.

For instance, when a Deviation is created in SimplerQMS, the system automatically sends reminders and notifications to responsible team members regarding their assigned Deviation Reporting tasks. Notification helps ensure employees are aware of their responsibilities and the due date to perform their tasks.

Investigation

After identifying and reporting the deviation, the next step is to conduct a thorough investigation to determine its root cause.

Root-cause analyses are particularly crucial for major or critical deviations, as they have a significant impact on product quality or compliance with regulatory requirements.

In cases where root-cause analysis is required, after completion, the investigation phase proceeds to assess the need for Corrective and Preventive Action (CAPA).

CAPAs are initiated depending on specific criteria established by the company, such as recurring issues and deviations that affect the overall product quality or regulatory compliance.

This systematic approach ensures appropriate actions are taken to address deviations, improve product quality, and maintain compliance with regulatory requirements.

SimplerQMS provides eQMS with an interconnected CAPA management module to address deviations and other issues if necessary. For instance, Issue Handlers can determine the need to escalate a deviation to a CAPA and link all documents to ensure traceability.

CAPA document is then created using a document template. Companies can use already provided templates by SimplerQMS and edit them as necessary or migrate their existing ones to the system.

Documentation

The deviation management process must be documented. This includes the documentation of the identification of the deviation, the investigation, the corrective action, and the preventive action. Deviation-related documents can be linked together to promote traceability of information.

An essential component of deviation management documentation is the audit trail, which maintains a chronological record of all actions and changes made during the process.

Audit trails provide transparency and accountability, as well as evidence that requirements have been met, facilitating efficient tracking of deviations throughout their lifecycle.

In SimplerQMS, deviation documents can be related to specific document versions using hyperlinks. This ensures that the actions performed are accurate and reflect the procedures and the specific versions at the time of the deviation.

Our system automatically records all actions performed in documents and generates a time-stamped audit trail. Companies can keep track of deviation-related documentation progress by monitoring document status in highly customizable views.

Implementation

During the implementation phase, corrective and preventive actions are put into effect to prevent the deviation from happening again in the future. Effectiveness checks should be conducted to ensure that the actions are having the desired effect.

Timely and effective implementation of these actions is essential to ensure continuous improvement and maintain product quality and compliance with regulatory requirements.

SimplerQMS enables companies to create and schedule effectiveness checks with just a few clicks. The system simplifies assigning responsible people and setting deadlines. Notifications and reminders are automatically sent to ensure effectiveness checks are performed on time.

What Is the Role of Deviation Management Software in Streamlining the Deviation Management Process?

Deviation management system software plays a critical role in streamlining the deviation management process. By automating many of the manual tasks involved in deviation management, the software can help companies identify, report, investigate, document, and resolve deviations more quickly and effectively.

SimplerQMS provides an eQMS software solution tailored for Life Science companies together with robust deviation management capabilities.

SimplerQMS enables users to easily create deviation documents using forms and templates. Pre-defined workflows guide users through the processes this way supporting compliance with the Life Science requirements. For example, after investigation, deviations can be directly escalated to the CAPA process while linking all relevant information together.

SimplerQMS supports compliance with several Life Science requirements, such as 21 CFR Part 211, 212, and 820, ISO 9001:2015, EU Volume 4 GMP Part I, ICH Q7, ICH Q10, ISO 13485:2016, MDR and IVDR, and more.

We help companies comply with regulatory requirements by providing comprehensive QMS process support inside the system.

Some of the QMS processes, besides deviation management, that the SimplerQMS solution supports include document management, change control, employee training, CAPA management, customer complaint management, audit management, supplier management, and more.

If you are considering an eQMS implementation, you can download our free eQMS Business Case template. The tool allows you to evaluate the economic benefits and time-saving potential that an eQMS brings and equips you to present robust findings to your management.

Final Thoughts

Deviation management is a systematic process used to identify, analyze, resolve, and record any events that differ from the standard protocols.

This systematic approach plays a vital role in maintaining the uniform and high quality of pharmaceutical products, ensuring that only safe and effective drugs reach the market.

Using manual paper-based or hybrid systems, some companies can manage deviations. However, leveraging QMS software with deviation management process support offers multiple advantages, making the entire deviation management process more efficient and streamlined.

SimplerQMS offers an eQMS software solution designed specifically for Life Science companies with robust deviation management capabilities.

Discover how SimplerQMS can help streamline your QMS processes. Book a personalized demo with our knowledgeable eQMS system experts today to experience its benefits firsthand.

The post Deviation Management Process in the Pharmaceutical Industry appeared first on SimplerQMS.

It is a critical part of quality management in the pharmaceutical industry, as it helps to ensure that changes are introduced in a controlled manner and that the impact of those changes is fully understood.

This article will discuss change control in the pharmaceutical industry, covering the different types of changes, classification categories, requirements, process flow, and best practices. We will also explore the role of eQMS software in change control management.

SimplerQMS provides eQMS software with comprehensive change control capabilities designed specifically for Life Science companies. You can book a demo to discover how SimplerQMS can support your company’s compliance and quality management efforts.

The following topics will be covered in this article:

• What Is Change Control in the Pharmaceutical Industry?
• What Are the Different Types of Changes?
• What Are the Different Change Classification Categories?
• What Are the Change Control Requirements in the Pharmaceutical Industry?
• What Is the Change Control Process Flow?
• What Are the Recommended Best Practices in the Change Control Process?
• What is the Role of Software in Streamlining Change Control Management?

What Is Change Control in the Pharmaceutical Industry?

Change control in the pharmaceutical industry is a set of controlled actions used to manage modifications to processes, systems, or documents that may impact product quality and safety.

It helps ensure that the modification does not alter the intended process output and adheres to all the quality requirements related to the specific product or process.

The pharmaceutical industry has varying definitions of change control depending on the regulatory requirements and regulatory agencies.

Change control definitions based on some of the distinct guidelines and regulations applicable to pharmaceutical companies are mentioned below.

• EudraLex Volume 4 GMP Annex 15:
  The European Union guideline for Good Manufacturing Practices (GMP) defines change control as a structured system where qualified representatives review changes that may impact validated facilities, systems, equipment, or processes, according to EU GMP Annex 15. The goal is to ensure and document that the system’s validated state is maintained.
• ICH Q10:
  The international guideline for the pharmaceutical quality system model defines the change management process as a systematic approach to proposing, evaluating, approving, implementing, and reviewing changes.
• FDA 21 CFR Part 211:
  The United States Food and Drug Administration (FDA) defines changes as written procedures that must be drafted, reviewed, and approved by the appropriate quality control team.

What Is the Objective of Change Control?

The objective of the change control process is to ensure that all changes are carefully evaluated, authorized, implemented, and recorded in a controlled manner to reduce potential risks and maintain compliance with regulatory requirements.

Why Is Change Control Needed?

Change control is needed to maintain the uniform and high quality of pharmaceutical products, ensuring they are safe, effective, and compliant with regulatory requirements.

By controlling changes, pharmaceutical companies can mitigate potential risks, document modifications, and ensure that alterations are well-justified. This also reduces disruptions to operations and enables optimal use of available resources.

When Is Change Control Required?

Change control is required whenever proposed or actual modifications or alterations are made to processes, systems, equipment, facilities, materials, or documents that could impact the quality, safety, or efficacy of products in the pharmaceutical industry.

Having a robust change control process allows pharmaceutical companies to manage different types of changes.

What Are the Different Types of Changes?

Changes are broadly categorized into two main types: planned and unplanned.

Unplanned Changes

An unplanned change is a modification that occurs unexpectedly and requires immediate attention.

These often result from unforeseen events, such as equipment failures, safety incidents, customer complaints, deviations from established procedures, and other events.

Deviations are considered unplanned changes, and it is important to have a process in place for properly managing deviations that impact product safety, efficacy, and quality.

Planned Changes

A planned change is an intentional and pre-approved modification implemented after a detailed evaluation and authorization through the change control process.

These changes are carefully considered, and their impact on product quality, safety, and compliance is assessed before implementation.

Change types are broad categories of modifications. A more detailed approach is the change classifications based on their impact and significance on the resulting product, process, or system.

What Are the Different Change Classification Categories?

Changes can be classified into three categories based on their impact:

• Minor changes
• Major changes
• Critical changes

Minor Changes

Minor changes are modifications with minimal impact on the resulting product, process, or system.

Minor changes usually involve minor adjustments or improvements that do not significantly affect product quality or safety. For example, changing the font size on product labels.

Major Changes

Major changes have a more substantial impact on the resulting product, process, or system.

Major changes may require careful evaluation and validation to ensure a uniform and high level of product quality. For instance, modifying the manufacturing process for a drug formulation.

Critical Changes

Critical changes are modifications that have a significant potential effect on product quality, safety, or efficacy.

Critical changes may demand rigorous assessment, validation, and regulatory approval. An example would be changing the active ingredient in a pharmaceutical product.

What Are the Change Control Requirements in the Pharmaceutical Industry?

Change control requirements in the pharmaceutical industry vary depending on the market companies operate and the applicable requirements.

Some requirements for the change control process include the following.

EudraLex Volume 4 GMP

The EudraLex Volume 4 GMP offers guidance for manufacturers of human and veterinary medicinal products within the EU on interpreting the GMP principles. As part of Good Documentation Practices, Chapter 4, Section 4.29 states that there must be written procedures and protocols for the change control process.

In Chapter 5, Section 5.25 outlines that any change in the manufacturing process, equipment, or materials, which may affect product quality and process reproducibility, should be validated.

Additionally, within Annex 15 Section 11, the qualification and validation guidelines provide specific details and instructions regarding change control. It emphasizes that quality risk management should be employed to assess planned changes and anticipate their effects on product quality, avoiding unintended consequences.

EU 1252/2014

The European regulation EU 1252/2014 specifies the GMP requirements that manufacturers and distributors of active substances for medicinal products must comply with.

The requirements for change control are outlined in Article 14. The requirements specify that companies must assess how changes to the manufacturing process may affect the quality of the active substance before implementing them.

FDA 21 CFR Part 211

The FDA regulation 21 CFR Part 211 establishes the current Good Manufacturing Practice (cGMP) requirements for finished pharmaceutical products.

The change control process is mentioned in the following sections:

• 21 CFR 211.22: Authorizes the Quality Control Unit to approve or disapprove changes. The company is responsible for providing quality control personnel with all necessary resources and facilities.
• 21 CFR 211.100: Describes the requirements of written procedures for production and process control, including changes. These procedures must be written by authorized personnel and approved by the Quality Control Unit. In the event of a deviation from written procedures, it must be recorded and justified.
• 21 CFR 211.160: Outlines the requirements of written procedures in a laboratory environment, covering various processes, including changes.

Our dedicated article provides a comprehensive explanation of cGMP, including its importance, requirements, and how to maintain compliance.

ICH Q10

The ICH Q10 is a guideline that specifies a model for an effective pharmaceutical quality management system.

Section 3.2.3 states that the change control process should provide a high level of confidence that no unintended consequences result from the change. Quality risk management should be used to assess proposed changes.

Pharmaceutical companies can utilize specific steps within the change control process to meet established requirements and systematically evaluate, authorize, document, and implement changes.

You can learn more about this guideline in our dedicated article about the ICH Q10 Pharmaceutical Quality System.

What Is the Change Control Process Flow?

The steps of change control process flow involve specific actions for managing changes to a product, process, or system.

The steps involved in the change control process will vary depending on the company and the change classification category.

We will discuss change control process steps and provide examples of how an electronic QMS (eQMS), like SimplerQMS, further streamlines each step of the change control process.

Common change control process flow steps are listed below:

1. Initiate Change Request
2. Perform Impact Assessment
3. Review Change Request
4. Approve Change Request Plan
5. Implement Change
6. Provide Training (As Applicable)
7. Monitor Change Effectiveness

1. Initiate Change Request

The first step of the change control process involves filling out a change request form or following a defined change control procedure to identify and formally document the proposed change.

Company criteria and internal procedures establish the necessity for change and can be based on change classification, such as minor, major, and critical, to implement alterations.

For example, minor changes may not require significant process alterations. In contrast, major and critical changes demand more rigorous evaluation before implementation.

SimplerQMS provides an eQMS software solution with a comprehensive change control management module.

Companies can easily classify changes when drafting change request documents by selecting the type and priority of change from the dropdown menus.

2. Perform Impact Assessment

Once the change request is initiated, an impact assessment may be conducted. This step involves evaluating the proposed change’s potential impact on product quality, safety, efficacy, and regulatory compliance.

Quality risk assessments may also be performed to identify potential risks associated with the change.

SimplerQMS helps ensure quality risk assessment tasks or any other tasks are performed on time. The system automatically sends reminders and notifications to the assigned people about activities’ required actions and due dates.

3. Review Change Request

The change request is reviewed by assigned personnel with the relevant qualifications.

All relevant information and data are examined during this stage.

SimplerQMS provides pre-defined workflows to guide users through the steps in the change request process flow. Routing documents for review and approval to the assigned persons is done with just a few clicks.

4. Approve Change Request Plan

After the impact assessment and change request review, the responsible person approves or rejects the change request plan.

Major or critical changes may require approvals from multiple people.

In SimplerQMS, change request plans are approved and signed off using 21 CFR Part 11 compliant electronic signatures for secure signing of documents. Users sign documents using unique identification codes and password combinations, ensuring accountability and traceability of all actions.

5. Implement Change

After approval and training, the approved plan of change is implemented in a controlled and systematic manner.

Implementing a change includes verifying that the necessary adjustments are made to processes, equipment, or documentation as required. Afterward, the change request is approved for closure.

6. Provide Training (As Applicable)

After the change control process, it is possible to provide training to all relevant personnel on the approved changes, if necessary.

Training ensures that everyone involved understands the new processes, procedures, and modifications related to the change. Adequate training is essential for a smooth and successful implementation of the change.

Effective communication ensures that everyone is aware of the change, its purpose, and its impact on their roles and responsibilities.

SimplerQMS offers robust training management capabilities, helping streamline training processes within the company.

For example, Training Managers can assign specific employees to relevant training groups and create learning rules. Employees in specific training groups can get automated notifications regarding retraining when related documents, such as SOPs (Standard Operating Procedures), are updated.

Each employee’s training assignment’s progress can be monitored via highly customizable views.

7. Monitor Change Effectiveness

Once the change is implemented, its performance is monitored and evaluated. This involves conducting an effectiveness check to evaluate the impact and success of the implemented change.

The monitoring process helps identify potential issues and ensures that the change delivers the desired results. During this phase, any deviations from expected results are identified and addressed.

With SimplerQMS, you can assign specific tasks to individuals responsible for assessing the effectiveness of changes. These tasks involve periodic reviews to ensure that the changes are working as intended.

The system can automatically send reminders and notifications regarding assessment due dates, helping to ensure effectiveness checks are carried out in a timely manner.

What Are the Recommended Best Practices in the Change Control Process?

Following best practices for change control processes helps pharmaceutical companies ensure that their change control process is effective and that changes are made in a safe and controlled manner.

Some of the recommended best practices for the change control process are listed below:

• Have a well-defined change control process: An organized and documented change control process that outlines the steps, responsibilities, and procedures for managing changes should be established. This ensures consistency and clarity throughout the change process.
• Keep clear change request documentation: All requests need to be thoroughly documented, including the reason for the change, its scope, potential impact, and proposed solutions. Proper documentation facilitates a comprehensive evaluation and decision-making process.
• Conduct risk assessments: A risk assessment for each proposed change must be performed to identify potential risks and their impact on product quality, safety, efficacy, and regulatory compliance.
• Perform testing and validation of changes: Changes with a high impact on product quality, safety, or efficacy should be tested and validated before implementation. These activities help ensure the change is well-controlled and does not introduce new risks or potential issues.
• Maintain comprehensive documentation and record-keeping: Documentation and record-keeping must be organized throughout the change control process. This includes change request forms, risk assessment reports, approval records, implementation plans, and effectiveness check records.

Following these best practices can help pharmaceutical companies ensure that their change control process is effective. Additionally, QMS software solutions help to automate and streamline the change control process, making it even more efficient and effective.

What is the Role of Software in Streamlining Change Control Management?

Traditionally, the change control process involved manual paper-based and hybrid systems, leading to excessive paperwork, potential for human error, and time-consuming management.

A more efficient solution is adopting an electronic Quality Management System (eQMS) offering built-in support for change control management. An eQMS software integrates all quality processes and centralizes all information in one system.

SimplerQMS provides eQMS software with comprehensive change control management capabilities. Our system is tailored to Life Science companies’ needs.

With our change control management software module, pharmaceutical companies can streamline change control processes from change request submission to final approval and successful implementation.

You can create change requests directly from a customer complaint and have a seamless workflow. Automated workflows facilitate routing change requests for review or approval and assigning specific people as responsible persons. The system automatically sends reminders and notifications to ensure the change request is handled on time.

SimplerQMS prevents unauthorized changes in documentation and processes by limiting access to the system. This way, change requests, and other specific documents can only be accessed by authorized personnel.

Documents in our eQMS are approved using electronic signatures. We offer 21 CFR Part 11 compliant electronic signatures software for secure and effortless document sign-off.

In addition to 21 CFR Part 11, our platform supports compliance with several Life Science requirements such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 210, 211, and 820, EU GMP, EU Annex 11, and more. By providing comprehensive QMS process support, SimplerQMS software helps companies achieve regulatory compliance.

SimplerQMS solution supports QMS processes, including document management, change control, employee training, deviation management, CAPA management, customer complaint management, audit management, supplier management, and more.

If you are unsure about the benefits of eQMS implementation, we recommend downloading our eQMS Business Case template. It offers a structured approach to assess the value of eQMS for your company, including factors like cost savings, improved efficiency, and enhanced regulatory compliance.

Present a compelling case to your management or board for adopting an eQMS solution using this template.

Final Thoughts

Change control is an essential part of quality management in the pharmaceutical industry.

By following a well-defined change control process, companies can ensure that changes to products, processes, and systems are made in a safe and controlled manner. This helps to ensure product quality, safety, and compliance with regulatory requirements.

To manage change control, companies traditionally used paper-based and hybrid systems. However, these systems are susceptible to errors, and document loss, and require physical space for storage.

As a solution to these challenges, pharmaceutical companies are increasingly embracing modern eQMS software solutions to streamline change control management.

SimplerQMS provides eQMS software with comprehensive change control and quality management capabilities specifically designed for Life Science companies.

You can schedule a free demo with one of our quality consultants to understand how our QMS software can help you streamline quality process management in your company.

The post Change Control in Pharma: Requirements and Process appeared first on SimplerQMS.

Standard Operating Procedures (SOPs) are an integral part of the routine operations in the pharmaceutical industry, and every department has its SOPs.

SOP management refers to the systematic process of creating, implementing, and maintaining these procedures. Proper management of SOPs helps ensure all procedures are adequately documented, regularly reviewed, and effectively communicated to the relevant personnel.

Having well-defined and well-maintained SOPs helps pharmaceutical companies consistently carry out routine operations, improve process efficiency, have uniform performance, as well as onboard new employees effectively.

This article will discuss the definition of an SOP, its importance, types, guidelines, format, management process steps, best practices, and the role of QMS software for SOP management in the pharmaceutical industry.

SimplerQMS provides eQMS software with robust document management capabilities designed specifically for Life Science companies. Schedule a demo and talk to our quality experts for a deeper look into our QMS software.

We will discuss the following topics in more detail:

• What Is the Definition of an SOP in the Pharmaceutical Industry?
• Why Are SOPs Important in the Pharmaceutical Industry?
• What Are the Different Types of SOPs in the Pharmaceutical Industry?
• What Are the SOP Management Guidelines in the Pharmaceutical Industry?
• What Is an SOP Format?
• What Are the SOP Management Process Steps?
• What Are the Best Practices for Writing an SOP in the Pharmaceutical Industry?
• What Is the Role of QMS Software for SOP Management?

What Is the Definition of an SOP in the Pharmaceutical Industry?

The SOP in the pharmaceutical industry is a validated and documented method that serves as the base of process activities, offering personnel clear step-by-step guidance for executing specific tasks to ensure compliance of company processes to internal policies and regulatory standards.

An SOP is used to streamline the pharmaceutical Quality Management System (QMS) processes, contributing to uniform and high product quality and safety.

Different regulations and standards are applicable depending on the market in which companies operate. These requirements governed by specific regulatory agencies have their definition for an SOP.

Below are more definitions of an SOP according to some of the main regulatory bodies.

Food and Drug Administration (FDA)

The FDA 21 CFR Part 211 defines SOPs as written procedures describing how to perform specific tasks or operations in producing pharmaceutical products.

They are designed to ensure drug products’ identity, strength, quality, and purity.

European Medicines Agency (EMA)

For EMA, the SOP refers to organized and easily verifiable instructions for operations.

According to EudraLex Volume 4 Good Manufacturing Practices (GMP) Chapter 4, they should be written in an imperative mandatory style.

International Organization for Standardization (ISO)

ISO specifies procedures as ways to carry out activities or processes.

They ensure that work is done consistently and to the required quality standards, as per ISO 9001:2015 for quality management systems.

World Health Organization (WHO)

According to the WHO guide to GMP requirements, SOPs are authorized written procedures providing general instructions for various operations, such as equipment operation, maintenance, cleaning, validation, and inspection.

What Is the Difference Between an SOP and a Work Instruction?

A standard operating procedure (SOP) is a document that provides high-level guidelines for a process. A work instruction is a more detailed step-by-step guidance document that provides accurate instructions on how to perform a particular task within that process.

Why Are SOPs Important in the Pharmaceutical Industry?

The SOPs are important in the pharmaceutical industry because they ensure that drug products are manufactured and handled in a consistent and controlled manner. This helps to reduce the risk of quality issues and noncompliances.

The main objective of an SOP is to ensure that tasks are performed consistently, correctly, and to the required quality standards, which can lead to several benefits for pharmaceutical companies.

Here are some reasons why SOPs are so important in the pharmaceutical industry.

Compliance With Regulations

The pharmaceutical industry is highly regulated, and SOPs help companies to comply with relevant requirements by ensuring consistent performance. This is important since noncompliance can result in monetary penalties, recalls, or legal action.

Ensure Quality and Safety

SOPs help ensure the quality and safety of pharmaceutical products by providing clear instructions on performing tasks. A comprehensive understanding of the procedure steps helps to reduce the risk of quality errors and contamination.

Improve Efficiency

Process efficiency in the pharmaceutical industry is improved by employing SOPs that streamline workflows and eliminate unnecessary steps. This can lead to increased productivity and reduced costs.

Transfer Knowledge

Procedures help to transfer knowledge within the pharmaceutical company by providing a way to document processes. SOPs are especially helpful for training new employees or moving employees between departments.

The SOPs ensure that a wide range of activities are performed correctly and effectively. Specific SOPs are tailored for each type of activity, ensuring precise steps are followed for each process.

What Are the Different Types of SOPs in the Pharmaceutical Industry?

There are different types of SOPs in the pharmaceutical industry. The SOP type varies depending on the departments, roles, and responsibilities.

The following are some examples of the most common types of SOPs in the pharmaceutical industry:

• Training SOP: Outlines training procedures, ensuring employees have the necessary knowledge and skills to perform their tasks.
• Safety SOP: Specifies the steps involved in ensuring the safety of employees and drug products. This includes procedures for handling hazardous materials, as well as procedures for responding to accidents and emergencies.
• Product Distribution SOP: Governs the distribution and transportation of pharmaceutical products. It ensures proper handling, storage, and documentation throughout the supply chain to maintain product integrity and prevent deviations during distribution.
• Cleaning SOP: Provides instructions for cleaning and sanitization processes within the pharmaceutical facility. It details cleaning agents, frequencies, and actions to maintain a sterile or non-sterile environment and prevent contamination.
• Production SOP: Covers the step-by-step procedures for drug manufacturing. It ensures consistency and compliance with GMP requirements, specifying the processes from raw materials to the finished product.
• Equipment Maintenance SOP: Outlines the steps in maintaining and calibrating critical equipment. This includes procedures for inspecting, testing, and repairing equipment.
• Quality Control SOP: Defines the steps involved in testing pharmaceutical products to ensure they meet established quality standards and specifications. This includes procedures for sampling, testing, and analyzing products.

In the pharmaceutical industry, there are different types of SOPs for each specific action that needs to be taken. The requirements for these processes are outlined by various guidelines, depending on the market in which the companies operate.

SimplerQMS provides a comprehensive eQMS that enables companies to store and manage various types of SOPs.

Our software utilizes secure cloud infrastructure to store all SOP-related documents and data. SOPs are accessible from anywhere and at any time. Team members can access documents and collaborate efficiently, whether in the office or remotely.

What Are the SOP Management Guidelines in the Pharmaceutical Industry?

In the pharmaceutical industry, SOP management guidelines encompass the regulations, standards, and requirements that dictate the creation, implementation, and maintenance of SOPs.

Below are some key guidelines applicable to the pharmaceutical industry.

FDA 21 CFR Part 211

Regulation 21 CFR Part 211 establishes the current Good Manufacturing Practice (cGMP) requirements for finished pharmaceutical products.

It requires pharmaceutical companies to have written SOPs for all aspects of drug manufacturing, including production, testing, and packaging.

Drug manufacturers must create and follow written procedures for production and process control to ensure their drug products have the intended identity, strength, quality, and purity, according to 21 CFR 211.100.

EudraLex Volume 4 GMP

The EudraLex Volume 4 GMP contains guidance for interpreting the principles of GMP for manufacturers of medicinal products for human and veterinary use within the EU member states.

It requires companies to have written SOPs for all aspects of pharmaceutical production, from quality control to documentation and personnel training.

Documents containing instructions should be approved, signed, dated, and organized in a clear and easy-to-understand way by authorized persons, as indicated in EU GMP Chapter 4 Section 4.3.

ICH Q7

The ICH Q7 provides guidelines and recommendations for the GMP requirements specific to manufacturing Active Pharmaceutical Ingredients (APIs).

Written procedures should be established for several processes, such as equipment maintenance, batch production, customer complaints, change control, and more.

SOPs related to the manufacture of APIs should be prepared, reviewed, approved, and distributed utilizing version control as per ICH Q7 Section 6.11.

WHO GMP Guideline

The WHO GMP Guideline is a framework to aid manufacturers in assessing their planned or existing documents describing their production methods.

It lists different types of SOPs as required documents for demonstrating compliance. The list includes SOPs related to facilities, equipment, production, quality control, quality assurance, and more.

The WHO GMP Guideline Section 6 states that quality assurance procedures should be in place to ensure that SOPs are enforced and properly used.

The specific guidelines that would apply to your pharmaceutical company will vary depending on the applicable regulatory requirements. It is important to know the applicable requirements to determine the necessary SOP types and their formats.

What Is an SOP Format?

An SOP format is a template used to write effective standard operating procedures.

There is no single SOP format that all pharmaceutical companies use. However, some common elements are found in most SOPs.

The SimplerQMS software solution allows pharmaceutical companies to create different types of SOPs using highly customizable templates. Companies can easily use their existing SOP templates inside the system and draft documents to their specific needs.

SOP documents can then be sent through an automated workflow for authoring, review, and approval.

Here is an example of a common format of SOP:

Header

The header includes essential information about the SOP, such as the title, SOP number, version, and effective date.

The information on the header helps identify the SOP and keeps track of its version number.

Purpose

The purpose section states the reason for creating the SOP.

This section defines the specific goals, objectives, or outcomes the procedure aims to achieve.

Scope

The scope outlines the boundaries and limitations of the SOP.

A well-described scope clarifies what the procedure covers and specifies the areas it does not address.

References and Related Documents

This section lists any external documents, regulations, or standards mentioned in the SOP.

A list of references provides sources for additional information and for demonstrating compliance with specific requirements.

Roles and Responsibilities

The roles and responsibilities section defines the individuals or job roles involved in executing the specific processes.

This part of the SOP clarifies who is responsible for each step or task.

Procedure

The procedure section is the core part of the SOP. It provides a comprehensive set of instructions for carrying out the process.

Each step should be clear, concise, and in chronological order.

Using active voice, bullet points instead of paragraphs, and short sentences are recommended.

Appendices

Appendices contain supplementary information, such as forms, templates, or supporting documents that complement the written standard operating procedure.

Revision History

The revision history lists the changes made to the SOP over time, including the version number, revision date, and a summary of the modifications.

This section helps ensure that employees are working with the most up-to-date SOP version. Providing an overview of how the SOP has developed over time and why specific changes were made.

Signatures

The signatures section contains the names, dates, times, and signatures of authorized individuals who have reviewed and approved the SOP. It ensures accountability and authorization.

Typical signatures in an SOP include:

• Prepared by: The signature of the person responsible for creating the SOP.
• Reviewed by: The signature of the individual who reviewed the SOP.
• Approved by: The signature of the individual who approved the SOP.
• Authorized by: The personnel’s signature granting permission for the SOP’s implementation. Usually, departmental heads approve SOP implementation.

These SOP elements collectively create a well-structured and comprehensive SOP, providing clear guidance for performing specific activities consistently and effectively. Having a complete SOP format facilitates access to information and a more streamlined SOP management process.

What Are the SOP Management Process Steps?

The SOP management process steps involve a series of actions aimed at creating, implementing, and maintaining standard operating procedures.

The typical SOP management process steps are listed below.

1. Preparation
2. Review
3. Approval
4. Implementation
5. Training
6. Maintenance

A brief overview of each process step is provided below, with examples of how these steps are streamlined using an eQMS.

1. Preparation

The first step in the SOP management process is to prepare for the creation of an SOP.

This involves identifying the need for an SOP, gathering information about the task that the SOP will describe, and developing a draft procedure.

The specific people who prepare SOPs in a pharmaceutical company will vary depending on the size and complexity of the company. Usually, an SOP writer is an individual who either performs the task or person that is responsible for leading the people doing the job.

SimplerQMS provides eQMS software with document templates to simplify the preparation of new SOPs. Companies can create different templates for specific types of SOPs using our customizable templates or migrate their own SOPs into the system.

2. Review

Once the draft has been developed, it needs to be reviewed by the appropriate people.

This includes the person responsible for implementing the SOP and any other personnel who may be affected by the SOP.

Within SimplerQMS, assigning responsible people for document review is simple. You can assign reviewers by selecting relevant people from a dropdown when creating the SOP.

Automated notifications and reminders are sent to inform users about their tasks. This helps prevent delays and ensures that responsibilities are promptly addressed.

3. Approval

After the review process, the SOP is approved by authorized personnel who have the authority to sign off on the procedure. This approval signifies that the SOP is ready for use.

For example, SimplerQMS allows you to route the document to the pre-defined approver(s) in the workflow. The SOP is approved using electronic signatures with unique username and password combinations.

Each change in the SOP status is registered in the time-stamped audit trail, providing a comprehensive record of actions taken and the users involved.

4. Implementation

Once approved, the SOP is implemented and put into practice.

After implementation, the SOP becomes an official document that guides employees in performing the specified tasks or processes.

In SimplerQMS, once an SOP update is implemented, the previous version of the SOP is retired to prevent the use of outdated procedures. New document versions are controlled using the software’s version control capabilities.

5. Training

Employees are trained on the SOP to ensure they understand the procedures and can follow them correctly. Training is essential to ensure process consistency and compliance with requirements.

To streamline this process, specific learning rules can be created in SimplerQMS to automatically send new or updated SOPs to all relevant people for training.

Training assignments in the system can include various materials for training, such as training videos, documents to learn, quizzes to complete, and more. All training records are stored in the system so that training can be tracked easily.

6. Maintenance

SOPs are living documents and may require updates over time due to changes in regulations, processes, or best practices. Regular maintenance and revision of SOPs help keep them up-to-date and relevant.

In SimplerQMS, users can define periodic review tasks for each SOP, specifying how often the document should undergo a review. As the SOP review date approaches, the software automatically notifies the designated reviewers or approvers, prompting them to do the review task.

To further improve user-friendliness and effectiveness, SOPs should be written with clarity and precision, employing best practices for SOP writing.

What Are the Best Practices for Writing an SOP in the Pharmaceutical Industry?

To maintain clarity and accuracy in standard operating procedures, it is essential to follow best practices for SOP writing.

Consider the following best practices for developing pharmaceutical SOPs:

Have a Clear and Concise Scope

The scope of an SOP should be clearly defined at the beginning of the document. This will help ensure that the SOP only covers the specific procedure or process it is intended for.

Use Plain Language

SOPs should be written in plain language that is easy to understand by anyone who needs to use them. Avoid using jargon or technical terms that the reader may not be familiar with.

Be Specific

The SOPs should be as specific as possible. Provide detailed and specific instructions for each step to leave no room for interpretation or ambiguity.

Use Diagrams and Illustrations

Incorporate visual aids like illustrations, flowcharts, and diagrams to supplement the textual descriptions, making complex processes easier to comprehend.

Get Input From Experts

Involve subject matter experts to validate the accuracy and completeness of the SOP, ensuring it reflects the best industry practices.

Review and Update the SOP Regularly

SOPs should be reviewed and updated regularly to ensure they are accurate and up-to-date. This is especially important if there are any changes to the procedures or processes they cover.

By following these best practices, pharmaceutical companies can develop SOPs that help ensure consistent process execution. The whole process can be further improved by implementing QMS software to streamline the process.

What Is the Role of QMS Software for SOP Management?

QMS software plays a crucial role in SOP management by facilitating the creation, maintenance, and control of standard operating procedures within a company. It streamlines the entire SOP lifecycle, from creation to approval to implementation and maintenance.

In some companies, the management of SOPs can be accomplished through paper-based or hybrid systems, which depend on company size and available resources.

However, these systems come with certain drawbacks, as they can be time-consuming and labor-intensive. Challenges may arise in tracking changes, potential document loss, the need for physical storage space, and other related issues.

A better alternative is an electronic Quality Management System (eQMS) software, which offers powerful SOP management capabilities.

SimplerQMS provides eQMS solutions specifically designed for Life Science companies.

With SimplerQMS, companies can benefit from features such as automated workflows, version control, and time-stamped audit trails.

We offer QMS software with robust document management capabilities that simplify the SOP creation, review, approval, and update process. The system is cloud-based and limits access to authorized personnel, ensuring that documents are secure.

The software promotes efficient collaboration among team members, as they can easily find and retrieve the SOPs they need using a search function. Controlled printing capability allows for managing the print or download of copies of SOPs and facilitates keeping track of all printouts.

Our eQMS platform helps companies achieve compliance with several Life Science requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 210, 211, and 820, EU GMP Annex 11, EU GMP, and more. The SimplerQMS solution supports companies in regard to compliance with regulatory requirements by providing comprehensive QMS process support.

The SimplerQMS solution supports several QMS processes, including document management, change control, audit management, employee training management, CAPA management, customer complaint management, supplier management, and more.

Discover the benefits of implementing an eQMS in your company with our eQMS Business Case template. Identify opportunities for efficiency, cost reduction, and improved compliance. Assess the advantages of an eQMS and present essential findings to management.

Final Thoughts

Effective SOP management is essential to ensure that SOPs promote consistency, standardization, and efficiency in the execution of processes within a company.

The core purpose of Standard Operating Procedures (SOPs) is to provide a comprehensive guide on how processes and routine operations are carried out by the company.

Although SOP management can be done using paper-based or hybrid systems, these methods often encounter issues such as lost documents and increased error-prone processes.

To address these challenges, companies utilize eQMS to manage SOPs. eQMS software, like SimplerQMS, provides robust document management features that streamline the creation, control, and archiving of SOPs.

With SimplerQMS, pharmaceutical companies gain access to SOP templates, automated workflows for process steps, document version control, and more, facilitating efficient and streamlined SOP management.

If you are interested in learning more about how SimplerQMS can help you streamline your quality management activities, we recommend you book a tailored demo today and talk to our system experts.

The post SOP Management in the Pharmaceutical Industry appeared first on SimplerQMS.

ICH Q10 provides a comprehensive model based on the International Standards Organization (ISO) quality concepts. It also incorporates relevant Good Manufacturing Practice (GMP) regulations.

The purpose of the guideline is to ensure the establishment of robust quality systems that support the consistent production of safe and effective pharmaceutical products.

This article provides an overview of the ICH Q10 Pharmaceutical Quality System, highlighting its importance and Quality Management System model. We also explore the role of eQMS software in implementing and maintaining the QMS that aligns with ICH Q10 principles.

There is a growing trend of Life Science companies adopting digital QMS solutions. These solutions provide an efficient and streamlined approach to managing quality processes.

SimplerQMS offers QMS software suited for pharmaceutical companies seeking to implement the ICH Q10 Quality Management System model. Schedule a personalized demo and talk to our experts to discover how SimplerQMS can streamline your company’s quality processes and help you work more efficiently.

Here is what we will discuss in this article:

• What Is the ICH Q10 Quality Management System?
• Why Is ICH Q10 Quality Management System Important?
• ICH Q10 Pharmaceutical Quality System Model
• Role of Pharmaceutical eQMS Software
• Frequently Asked Questions

What Is the ICH Q10 Quality Management System?

The ICH Q10 Quality Management System is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.

It is established by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

ICH Q10 applies to systems supporting the production of drug substances and drug products, including biotechnology and biological products, throughout their entire lifecycle.

These systems control essential processes such as formulation development, drug manufacturing, retention of documentation, quality control, change management system, CAPA system, and more.

Life Science companies adopting ICH Q10 are among others pharmaceuticals and biotechnological manufacturers, and contract research organizations (CROs).

ICH Q10 is part of the tripartite guideline that includes ICH Q8 and ICH Q9.

These guidelines collectively cover different aspects of product development and manufacturing in the pharmaceutical industry.

Let’s explore what each guideline, ICH Q8, Q9, and Q10, covers:

• ICH Q8 (Pharmaceutical Development): This guideline provides guidance on applying scientific approaches and quality risk management during the development and manufacturing of pharmaceutical products.
• ICH Q9 (Quality Risk Management): This guideline focuses on systematic approaches to quality risk management, ensuring that companies address potential risks effectively in their operations.
• ICH Q10 (Pharmaceutical Quality System): This guideline provides a model for the quality management system in the pharmaceutical industry, ensuring consistent quality throughout the product lifecycle.

ICH Q10 is built upon the foundation of regional Good Manufacturing Practice (GMP) requirements and is intended to be used in conjunction with them.

SimplerQMS provides efficient QMS software for pharmaceutical companies with integrated quality management processes. It helps ensure compliance with the ICH Q10 guideline, GMP requirements, FDA regulations, ISO standards, and more.

Why Is ICH Q10 Quality Management System Important?

The ICH Q10 Quality Management System is important because it provides a structured framework for pharmaceutical companies to establish and maintain a culture of quality.

This framework helps companies to ensure compliance with regulatory requirements, mitigate risks, and continually improve their processes and products.

ICH Q10 Pharmaceutical Quality System Model

ICH Q10 Pharmaceutical Quality System Model provides guidelines and principles for establishing, implementing, and maintaining a quality management system in the pharmaceutical industry and consists of four core areas.

• Pharmaceutical Quality System: Encompasses the overall quality system, including objectives, quality manual, quality risk management, and knowledge management.
• Management Responsibility: Focuses on the role of management in establishing quality objectives, allocating resources, and ensuring appropriate communication within the company.
• Continual Improvement of Process Performance and Product Quality: Emphasizes the need for ongoing improvement in process performance and product quality through data analysis, corrective and preventive actions, and customer feedback.
• Continual Improvement of the Pharmaceutical Quality System: Highlights the importance of continually improving the quality system itself through the use of management review, revisions to quality policy, and assessment of system performance.

This section will discuss the contents of the guideline model, represented in the ICH Q10 Pharmaceutical Quality System Diagram below.

At the top of the diagram, the Pharmaceutical Quality System (PQS) covers the entire product lifecycle stages, including development, technology transfer, manufacturing, and discontinuation. It complements GMP requirements specific to each country and also applies to investigational products.

The management responsibilities should be present across all stages of the product lifecycle, just like the PQS elements that form one of the pillars of the model.

The lower horizontal bars represent the enablers – knowledge management and quality risk management. These enablers support the PQS goals of product realization, state of control, and continual improvement.

In the following sections, we will further explore the ICH Q10 Pharmaceutical Quality System diagram to understand its key parts and their relations better.

ICH Q10 Lifecycle Stage Goals

The product lifecycle stage goals include the following technical activities for new and existing products according to the ICH Q10 section 3.1.

• Pharmaceutical Development
• Technology Transfer
• Commercial Manufacturing
• Product Discontinuation

Pharmaceutical Development

In the pharmaceutical development phase, the goal is to design products and plan the steps for the manufacturing process.

The company should focus on maintaining consistent process performance and meeting the needs of patients, healthcare professionals, regulatory authorities, and internal customers.

The technical activities conducted in this phase are:

• Developing drug substances
• Developing formulations that include both container and closure systems
• Developing analytic methods
• Developing manufacturing processes and plans for the scale-up
• Manufacture of investigational products

ICH Q10 applies to the development and manufacture of all pharmaceutical products. This also applies to pharmaceutical products still in the development stage and have not yet been approved for marketing, the so-called investigational products.

Technology Transfer

The technology transfer phase aims to transfer knowledge about processes and products from the development to the manufacturing phase.

This phase involves the following technical activities:

• Transfer of products from development to manufacturing
• For marketed products, transfer between manufacturing and testing sites

Commercial Manufacturing

The goal of the commercial manufacturing phase is to help pharmaceutical companies to manufacture products through a process of continual improvement and a state of control.

The pharmaceutical quality system should ensure high and uniform product quality, process performance, suitable controls, identification and evaluation of improvement opportunities, and knowledge growth.

The technical activities that companies must perform are:

• Acquire and control materials
• Provide facilities, equipment, and utilities
• Fabricate packaging materials and labels
• Store, release, or distribute the manufactured products
• Ensure quality control and assurance

Product Discontinuation

Product discontinuation activities aim to manage the final stage of the product lifecycle effectively.

During this phase, the following technical activities should be carried out:

• Management of document retention and sample retention
• Performing continual product evaluation and reporting

Managing the product lifecycle stage goals generates a high volume of documentation that must be handled appropriately to ensure compliance with ICH Q10.

SimplerQMS offers QMS software with robust document management capabilities that simplify the process of document creation, review, approval, retirement, and storage, promoting efficient collaboration among team members.

Our search and retrieval capabilities make it easy to locate and access relevant documents when needed. This ensures quick access to up-to-date information and enables timely responses to inquiries.

Management Responsibilities

Management responsibility states that leadership is essential in establishing and maintaining a company-wide commitment to quality, as per ICH Q10 section 2.

Effective leadership ensures that all company employees understand the significance of quality and are dedicated to upholding it throughout all aspects of the pharmaceutical quality system.

The management should provide guidance, allocate necessary resources, and create a culture that values and prioritizes quality.

Commitment

Management commitment is crucial for ensuring an effective pharmaceutical quality system. Senior management is responsible for establishing the system, defining roles and responsibilities, and ensuring their implementation throughout the company.

In addition, management should actively participate in several tasks, such as:

• System design and maintenance
• Provide support for PQS implementation
• Establish effective communication channels
• Define roles and responsibilities
• Conduct management reviews
• Promote continual improvement
• Allocate necessary resources
• And more

Quality Policy and Planning

Senior management should create a quality policy that outlines the company’s intentions and approach to quality.

The policy is an essential part of the QMS documentation and should encompass compliance with regulatory requirements, emphasizing the continual improvement of the pharmaceutical quality system.

Management should also define and communicate the quality objectives for implementing the quality policy.

Additionally, regular reviews and monitoring of key performance indicators (KPIs) of quality should be conducted.

Resource Management

Management should allocate adequate and appropriate resources to specific products, processes, or sites to ensure the effective implementation and maintenance of the pharmaceutical quality system.

Examples of resources include, but are not limited to, the following:

• Human resources
• Finances
• Materials
• Facilities
• Equipment

Internal Communication

Management should establish and implement effective communication processes within the company to ensure the flow of relevant information between all levels and departments.

These processes should also facilitate the appropriate and timely escalation of product quality and other issues when necessary.

Change in Product Ownership

During product ownership transitions, such as acquisitions, management should acknowledge the complexity of the situation and prioritize the seamless transfer of relevant information and processes.

In addition, it is important to identify and clarify the responsibilities of all companies involved in the process.

Pharmaceutical Quality Management System Elements

The four elements of a pharmaceutical quality management system, as outlined in ICH Q10 section 3.2, are the following:

• Process performance and product quality monitoring system
• Corrective action and preventive action (CAPA) system
• Change management system
• Management review of process performance and product quality.

These four elements work together to establish a comprehensive pharmaceutical quality system that helps ensure the production of safe and effective products while promoting continual improvement.

The PQS elements may be required in part by regional GMP regulations. Still, the ICH Q10 quality management system model aims to enhance them to promote a lifecycle approach to product quality.

Process Performance and Product Quality Monitoring System

Pharmaceutical companies should plan and implement a monitoring system to ensure control over process performance and product quality.

The monitoring system should ensure consistent product quality and identify opportunities for improvement.

Handling process deviations to ensure performance and product quality effectively is essential.

Using an eQMS such as SimplerQMS with the Deviation Management module, companies can streamline the investigation, documentation, and resolution of issues. 

Our software allows companies to relate deviation documents with products, manufacturing processes, and vendors, facilitating the tracking of related data and helping investigate root causes for the issue.

Corrective Action and Preventive Action (CAPA) System

Companies should have a system for implementing corrective and preventive actions (CAPA) based on various sources, such as complaints, deviations, recalls, audit findings, product monitoring data, and more.

Investigations should be conducted using a structured approach to determine the root cause. The level of investigation should be proportional to the level of risk, following ICH Q9 guidelines.

The CAPA methodology should lead to better understanding and improvements in products and processes.

SimplerQMS solution also includes a CAPA Management module that simplifies and automates the corrective and preventive action process.

The software simplifies the escalation of recorded issues to CAPA processes allowing a seamless and closed-loop workflow.

Pharmaceutical companies can streamline CAPA activities for efficient and effective quality issue management, including data collection, routing, notifications, approvals, and follow-up.

Change Management System

An effective change management system should be in place to evaluate, approve, and implement changes properly.

Expert teams with relevant expertise and knowledge should evaluate proposed changes to ensure their technical justification.

After implementation, an evaluation should be conducted to confirm that the change met its objectives.

SimplerQMS offers robust Change Control Management capabilities enabling companies to create, document, and effectively manage all changes.

By utilizing our software, companies can benefit from automatic reminders and notifications that keep employees informed about change requests and their associated activities.

Management Review of Process Performance and Product Quality

Management reviews should ensure that process performance and product quality are effectively managed throughout the lifecycle.

The review process may vary in frequency and level of detail, depending on the company’s size and complexity. It should include efficient communication and escalation mechanisms to address quality issues and involve senior management for in-depth evaluation.

The management review should include the following:

• Review of results from regulatory inspections, audits, and commitments to regulatory authorities.
• Review of quality assessments of customer satisfaction, process, and product monitoring conclusions, and the effectiveness of changes.
• Review of follow-up actions implemented based on previous management reviews.

Knowledge Management and Quality Risk Management

Knowledge management and quality risk management are essential for effectively implementing the pharmaceutical quality system model, according to ICH Q10 section 1.6.

These practices serve as enablers, allowing companies to achieve the objectives outlined in ICH Q10 by facilitating science-based and risk-informed decisions regarding product quality.

What is Knowledge Management?

Knowledge management is the systematic acquisition, analysis, storage, and dissemination of information throughout a product’s lifecycle, from development to commercialization and even discontinuation.

It includes managing product and process knowledge gained through scientific approaches during development activities. Effective pharmaceutical document management processes are essential to ensure that all knowledge is recorded and readily available to relevant individuals.

Various sources contribute to this knowledge, such as:

• Prior knowledge
• Pharmaceutical development studies
• Technology transfer
• Process validation studies
• Manufacturing experience
• Innovation
• Continual improvement
• Change management activities

What is Quality Risk Management?

Quality risk management involves a proactive approach to identify, scientifically evaluate, and control potential risks to ensure product quality.

With SimplerQMS’s Risk Management module, companies can develop risk mitigation plans by defining control measures, implementing preventive actions, and establishing contingency plans.

The software provides a platform for documenting risk mitigation strategies and integrating them with other quality processes to facilitate traceability.

Continual Improvement of the Pharmaceutical Quality System

Continual improvement in the pharmaceutical quality system involves various activities to manage and enhance its effectiveness, as per ICH Q10 section 4.

These activities include ongoing evaluation, analysis, and implementation of improvements to ensure the system delivers uniform and high-quality pharmaceutical products.

Management Review of the Pharmaceutical Quality System

Management should conduct regular reviews of the pharmaceutical quality system using a formal process. These reviews should include evaluating the achievement of quality system objectives and assessing performance indicators that monitor the effectiveness of processes.

The PQS performance indicators cover areas such as:

• Complaints
• Deviations
• CAPA
• Change management
• Feedback on outsourced activities
• Risk assessments
• Internal audits
• Regulatory inspections
• Customer audits
• And more

The outcomes of management review and monitoring of the quality system may lead to several outcomes, including:

• Improvements to the quality system and processes
• Allocation or reallocation of resources
• Training of personnel
• Revisions to quality policy and objectives
• Documentation and communication of review results and actions

Additionally, any relevant issues identified during the review may be escalated to senior management for appropriate attention and resolution.

Internal and External Factors Impacting the PQS

Management should actively monitor various internal and external factors to ensure the effectiveness and adaptability of the pharmaceutical quality system.

Factors monitored by management can include:

• Emerging Regulations: Management should keep up with the latest regulatory requirements, industry guidance, and any emerging quality issues that could impact the PQS.
• Innovations for Enhancing the PQS: Management must be attentive to developments in technology, processes, and methodologies that can contribute to improving the systems.
• Changes in Business Environment: Management should monitor shifts in market trends, customer expectations, and internal organizational goals.
• Changes in Product Ownership: Management must monitor and assess any transitions in ownership to ensure the seamless integration of quality processes, responsibilities, and information.

Role of Pharmaceutical eQMS Software

Pharmaceutical electronic Quality Management System (eQMS) software plays an important role in supporting the implementation of the ICH Q10 guidelines.

The eQMS software can help pharmaceutical companies to improve the quality of their products and services and to comply with regulatory and customer requirements. It automates and streamlines quality processes, enhances communication and collaboration, and promotes a culture of continual improvement.

Although the ICH Q10 Quality System Model can be implemented using a manual paper-based or hybrid QMS, eQMS software provides further improvements.

Paper-based and hybrid systems, while suitable for small companies with sufficient resources, have inherent challenges and limitations. They are prone to errors and damaged documents and require physical space for storage, leading to inefficiencies and potential data loss.

On the other hand, eQMS software offers significant advantages in terms of efficiency, accuracy, and compliance. It provides a digital platform to create, store, and access documents electronically.

SimplerQMS provides fully validated pharmaceutical QMS software.

SimplerQMS offers all Life Science QMS modules integrated to optimize quality management processes. These include document management, CAPA management, change control, employee training, deviation, complaint, supplier, audit, risk management, and more.

Our system helps companies to achieve regulatory compliance with several Life Science requirements, such as GMP guidelines, ICH Q10, FDA 21 CFR Part 11, 210, and 211, EU GMP Annex 11, ISO 9001:2015, and many others.

To better understand the benefits of implementing an eQMS solution, we suggest downloading our eQMS Business Case template.

This valuable tool provides a structured approach for assessing the value of an eQMS tailored to your company’s needs. It also facilitates effective communication of your findings to management. Using a business case analysis, you can explore potential efficiency increases, cost savings, and compliance improvements.

Frequently Asked Questions

What is Q10 in ICH?

The Q10, in the context of ICH, refers to the quality guideline for the pharmaceutical quality system model. The ICH Q10 outlines requirements for implementing a pharmaceutical quality system to ensure the consistent quality of pharmaceutical products throughout their lifecycle.

What Is the Latest Version of ICH Q10?

The latest version of ICH Q10 is the Step 5 version, published in June 2008. Until this article’s publication date (July 2023), there have been no subsequent revisions to the guideline.

What Is the Scope of ICH Q10?

The scope of ICH Q10 is to guide for implementation of a quality management system in the pharmaceutical industry. It applies to the systems involved in developing and manufacturing pharmaceutical drug substances and drug products throughout their lifecycle.

Applying the elements outlined in ICH Q10 should be tailored to each stage of the product lifecycle, considering each stage’s unique characteristics and objectives. The product lifecycle encompasses pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation for new and existing products.

What Are the Objectives of ICH Q10?

The objectives of ICH Q10 aim to achieve three main goals.

Firstly, it aims to establish, implement, and maintain a system that delivers products meeting the quality requirements of customers and regulatory authorities. This objective emphasizes the importance of product realization.

Secondly, the model emphasizes developing and utilizing effective monitoring and control systems to ensure process performance and product quality. This objective aims to maintain a state of control throughout the processes.

Thirdly, the model promotes continual improvement. It encourages identifying and implementing improvements for consistent product quality, process efficiency, and innovation. Quality risk management is essential in prioritizing improvement areas within the system.

What Are the Benefits of Implementing the ICH Q10 Pharmaceutical Quality System?

The implementation of ICH Q10 can provide significant benefits to pharmaceutical companies. For instance, one of the most important benefits of ICH Q10 is to ensure uniform and high product quality and safety.

An effective Pharmaceutical Quality System (PQS) ensures the production of uniform and high-quality products that comply with regulatory requirements. This helps to prevent recalls, rework, and other quality issues, saving companies money and protecting patients.

Another benefit of ICH Q10 is cost reduction. ICH Q10 implementation helps to identify and reduce unnecessary costs associated with quality issues. With ICH Q10, companies improve efficiency and productivity, leading to further cost savings.

ICH Q10 helps to foster a culture of continual improvement by implementing risk management principles and tools to proactively identify, assess, and control risks across the product lifecycle.

Finally, ICH Q10 helps to improve regulatory harmonization. Compliance with ICH Q10 guidelines aligns companies with international guidelines, facilitating inspections and reducing the risk of non-compliance.

How Can Companies Ensure Compliance With the ICH Q10 Pharmaceutical Quality System?

Companies can ensure compliance with the ICH Q10 Pharmaceutical Quality System by following the requirements outlined in the guidance and implementing an internal audit process to ensure adherence to these requirements.

Here are some examples of key steps to ensure compliance with ICH Q10:

• Familiarize themselves with the ICH Q10 guidelines: Companies should thoroughly understand the requirements and recommendations outlined in the ICH Q10 guidelines.
• Conduct a gap analysis: Thoroughly evaluate the company’s existing quality management system against the requirements of ICH Q10. This gap analysis will help identify areas where the company’s current practices align with or deviate from the guideline.
• Implementing a risk-based approach to quality: Identify and assess risks to quality at all product lifecycle stages. Take steps to mitigate those risks.
• Ensure adequate training and awareness: Provide appropriate training to employees to ensure they understand the requirements applicable to their roles and responsibilities.
• Having a well-documented PQS: Have clear documentation describing the PQS and its implementation.
• Conduct regular audits and reviews of the PQS: Periodic inspections should be conducted to ensure that the PQS is effective and implemented correctly.
• Continually improve the quality system: Foster a culture of continual improvement by implementing corrective and preventive actions, analyzing quality data, conducting risk assessments, and actively seeking opportunities for improving the PQS.

What is the Difference Between PQS and QMS?

PQS (Pharmaceutical Quality System) and QMS (Quality Management System) are both quality management systems. The main difference between them is that PQS is specifically designed for the pharmaceutical industry, while QMS is a broader system applicable to any industry.

PQS refers to the quality system implemented by a pharmaceutical company to ensure the quality of its products throughout its lifecycle. It encompasses various elements, including process performance, product quality monitoring system, CAPA system, change management system, and management review, all aimed at achieving and maintaining product quality.

QMS is an overall quality system that defines the policies, processes, procedures, and responsibilities required to ensure that a company’s products or services consistently meet customer and regulatory requirements.

Final Thoughts

The ICH Q10 guideline, also known as the ICH Q10 Pharmaceutical Quality System (PQS), provides a comprehensive framework for pharmaceutical companies to effectively manage quality throughout the product lifecycle.

To implement an effective PQS model, pharmaceutical companies are increasingly adopting eQMS solutions. These solutions streamline quality processes and simplify compliance with regulatory requirements.

SimplerQMS offers an eQMS tailored specifically for pharmaceutical companies. The software automates and streamlines quality processes and supports compliance with ICH Q10 and other regulations, which include GMP, ISO 9001:2015, FDA 21 CFR Part 11, 210, 211, and more.

Want to learn more about how SimplerQMS can support your company QMS? Then book a personalized demo with our experts today and see how our eQMS solution can help you streamline and automate your quality management processes.

The post ICH Q10 Pharmaceutical Quality System (and Role of an eQMS) appeared first on SimplerQMS.

The QMS must reflect the relevant regulatory requirements applicable to the industry and company. In the pharmaceutical industry, some of the important quality standards and guidelines are ISO 9001:2015 and ICH Q10.

This article will cover what quality is in the pharmaceutical industry, the Pharmaceutical Quality Management System, some pharmaceutical QMS elements and requirements, and the role of quality management software.

Here is everything you will learn in this article:

• Definition of Quality in the Pharmaceutical Industry
• What is Pharmaceutical Quality Management System (QMS)?
• Applicable Pharmaceutical QMS Regulations and Standards
• Elements of Pharmaceutical Quality Management System
• Role of Pharmaceutical Quality Management Software

Definition of Quality in the Pharmaceutical Industry

Quality in the pharmaceutical industry refers to the degree to which a drug substance or product meets its intended use and fulfills its inherent properties. This definition includes essential attributes like the drug’s identity, strength, and purity.

The quality of a drug is critical for patient safety and effective treatment. If a drug is contaminated or not pure, it could cause harm to patients. Similarly, if a drug is not potent enough, it may not be effective in treating the condition for which it was intended.

Before pharmaceutical products are approved for human use, they must comply with regulatory requirements. In this regard, a Pharmaceutical Quality System (PQS) includes all processes of a system that helps ensure quality in the pharmaceutical product lifecycle.

What is Pharmaceutical Quality Management System (QMS)?

Pharmaceutical Quality Management System (QMS) is a comprehensive collection of policies, processes, and procedures designed to ensure and maintain uniform and high quality in the production of pharmaceutical products.

The QMS must reflect the specific needs of the pharmaceutical company and applicable regulatory requirements.

A robust Pharmaceutical Quality System (PQS) that reflects the applicable requirements can also help pharmaceutical companies to mitigate risks, improve customer satisfaction, and streamline quality processes.

The pharmaceutical quality management system includes several processes, such as:

• Document management
• Change control
• Training management
• Audit management
• CAPA management
• Deviation management
• And others

The quality system uses monitoring methods such as Quality Assurance to prevent quality deviations and emphasizes quality system documentation to record all problems and their solutions.

You can read our guide on what Quality Management System (QMS) is to learn more.

SimplerQMS provides QMS software for the pharmaceutical industry to help companies streamline all quality processes in one solution. You can easily manage documents, changes, training, audits, deviations, CAPAs, suppliers, equipment, and much more.

Applicable Pharmaceutical QMS Regulations and Standards

Establishing and working according to the Quality Management System (QMS) is a requirement in the pharmaceutical industry. To ensure uniform and high-quality products, companies need to implement a QMS that reflects the requirements applicable to them.

The company is responsible for complying with the relevant regulations and standards, which depend on many factors, including geographical location, product type, and target market.

Some of the most common standards and regulations applicable to the pharmaceutical QMS are described below.

International Organization for Standardization (ISO)

The International Organization for Standardization (ISO) is an international body developing standards for various industries, including Pharmaceuticals. The current standard for Quality Management Systems (QMS) is ISO 9001:2015, and previously it was ISO 9001:2005.

Some pharma companies use this standard to improve performance and ensure that their QMS complies with the requirements for quality.

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal collaborative arrangement between international Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use.

The PIC/S publishes guidance documents such as the PIC/S GMP Guides that specify various requirements for pharmaceutical companies, including a pharmaceutical quality management system. The requirements in the PIC/S GMP are equivalent to the EudraLex Volume 4 GMP in terms of good manufacturing practice guidelines.

Pharmaceutical companies use PIC/S GMP guidelines to provide a framework for quality management systems, manufacturing processes, and control systems to ensure products are safe, effective, and of uniform and high quality.

The guides cover various aspects of GMP compliance, such as:

• Premises and equipment
• Personnel
• Documentation
• Quality control
• Complaints and product recall
• Self-inspection

ICH Guideline Q10

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a non-profit association under Swiss law. It aims to achieve greater pharmaceutical requirements harmonization worldwide.

The combination of the letter Q and specific numbers, such as Q8, Q9, etc., designates the Quality guidelines.

The Q10 guideline is for the Pharmaceutical Quality System.

It provides a consolidated structure for the quality procedures based on established standards, regulations, and guidelines, including:

• ISO
• cGMP
• ICH Q8 Pharmaceutical Development
• ICH Q9 Quality Risk Management

We recommend reading our article on the ICH Q10 Pharmaceutical Quality System if you want to know more about this guideline. You will also learn about the role of an electronic QMS (eQMS) in helping achieve compliance with ICH Q10.

Current Good Manufacturing Practice (cGMP)

The current Good Manufacturing Practices (cGMP) are regulations enforced by the Food and Drug Administration (FDA), the US federal agency responsible for the safe production of drugs.

The product must be safe for human use, with quantity, quality, and purpose taken into consideration. The output must be free from contamination and prevent the mix-up of one product with another.

You can check out our article for a brief introduction to cGMP regulations.

The FDA inspects drug manufacturers for cGMP compliance. Non-compliance with cGMP regulation may lead to product recalls when deemed necessary upon investigation. Failure to follow the subsequent FDA directions can result in seizure, fines, and jail time.

Feel free to read our article about how GMP compliance is reflected in QMS to learn more about GMP-compliant quality management systems.

FDA 21 CFR Part 210

The 21 CFR Part 210 regulation specifies the minimum cGMP requirements for drug manufacturing, processing, packing, and storage to ensure product safety, quality, and purity.

Compliance with this regulation is mandatory for pharmaceutical companies marketing and selling their products in the United States.

FDA 21 CFR Part 211

21 CFR Part 211 specifies the cGMP requirements for finished Pharmaceuticals.

This regulation covers the following areas:

• Quality control
• Qualification and skills of the personnel
• Buildings and facilities
• Ventilation and air filtration system
• Equipment cleaning and maintenance
• Product labels
• Warehouse requirements.

21 CFR Part 11

The 21 CFR Part 11 regulates how electronic records are developed, maintained, and stored. It also describes how the relevant supervisors authorize these documents using electronic signatures.

If you want to learn more about this regulation, read our article on 21 CFR Part 11 requirements.

EU GMP Annex 11

The EU GMP Annex 11 provides good manufacturing guidelines for computerized systems.

When replacing a manual process with a computerized system, it is important to ensure that product quality, process control, and quality assurance are not compromised. Moreover, the overall risk of the process should not increase.

It also includes guidelines for the following topics:

• Data Storage
• Security
• Electronic Signature
• Batch release
• Personnel
• Risk Management

ISPE GAMP5

The Good Automated Manufacturing Practice 5 (GAMP5) is a guideline developed by the International Society for Pharmaceutical Engineering (ISPE) for computerized systems.

The goal of GAMP is to provide a cost-effective framework of best practices that ensures computerized systems are effective, of high quality, and compliant with applicable regulations while also being suitable for their intended use.

SimplerQMS provides an eQMS solution tailored to the pharmaceutical industry. The system supports compliance with ISO, ICH, cGMP, EU, and PIC/S GMP requirements. It is also validated in accordance with ISPE GAMP5 and is re-validated upon new version releases or standard updates, allowing you to save time and focus on value-adding activities.

Our software complies with FDA 21 CFR Part 11 and EU GMP Annex 11, ensuring compliance with electronic records, electronic signatures, and computerized system manufacturing guidelines.

Elements of Pharmaceutical Quality Management System

A Pharmaceutical Quality System comprises numerous elements and QMS processes. There is no “fixed” implementation scheme. The drug manufacturer can integrate these processes as per the product and intended market requirements.

This article will also provide examples of how QMS software can simplify and optimize processes.

Some of the elements of the product lifecycle in ICH Q10 are the following:

• Process performance and product quality monitoring system
• Corrective action and preventive action (CAPA) system
• Change management system
• Management review of process performance and product quality

Process Performance and Product Quality Monitoring System

The process performance and product monitoring system is an integral part of a company’s efforts to deliver a uniform and high-quality product. It shows the company’s commitment to sustained resources and control.

Process performance and product quality monitoring are applied to four stages of the product lifecycle:

• Pharmaceutical development: The knowledge gained about the process and product during development and monitoring can be utilized to create a manufacturing control plan.
• Technology transfer: During scale-up activities, monitoring can indicate process performance and successful integration into manufacturing.
• Commercial manufacturing: A robust system must be implemented for monitoring process performance and product quality to ensure consistent control and identify opportunities for improvement.
• Product discontinuation: Stability testing and monitoring should continue to the completion of the studies, even after manufacturing ceases.

Risk assessment techniques can be used to detect shortcomings in process stages. Specialized tools and feedback can also be used to analyze given parameters.

Production personnel and the Quality Department check the inspection system randomly to identify faults or malfunctions.

Luckily, a tool like Deviation Management Software by SimplerQMS automates data collection, routing, and notification of overdue activities. As a result, monitoring your product and process performance and safety becomes much easier.

Corrective Action and Preventive Action (CAPA) System

Corrective Action and Preventive Action (CAPA) is a system for identifying the causes of issues and preventing them from recurring in the future.

Complaints, deviations, audit findings, and other issues can be escalated to a CAPA. Once the decision regarding the escalation to a CAPA has been made, the CAPA form is filled.

The CAPA structure and CAPA form can be different in each company, but mainly it consists of the following information:

• The department where process deficiency is found
• Issue detail and its implications
• The impact of the error on the process or product
• Corrective action to resolve the problem
• Preventive action to prevent the recurrence of the issue
• Due date to implement the corrective and preventive actions
• Next review date to assess the effectiveness of corrective action

The typical CAPA process follows the steps illustrated below.

After necessary corrective and preventive actions are applied, the CAPA is sent again to the responsible persons for approval. The CAPA is closed and documented as part of the records upon approval.

The CAPA process is applied in different product stages, including pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation, with a focus on feedback, feedforward, continuous improvement, and periodic checks of the CAPA effectiveness.

The process presented in the example above can easily be automated with CAPA Management Software. It automates data collection, routing, follow-ups, notifications, and escalation of overdue activities allowing you to manage corrective and preventive actions more effectively.

To better understand how this process works, you can read our article about what CAPA is in the pharmaceutical industry.

Change Management System

Pharmaceutical companies must have a change control management system to control and manage all changes made to documents and processes.

The change management system can be applied to the product lifecycle in different stages:

• Pharmaceutical Development: Changes during the development process should be documented, and the change management process’s formality should match the pharmaceutical development stage.
• Technology Transfer: The process changes made during technology transfer activities should be managed and documented.
• Commercial Manufacturing: The quality unit’s supervision should ensure that there is adequate scientific analysis and evaluation based on risk for a change.
• Product Discontinuation: Any modifications made after discontinuing the product should still undergo a suitable change management process.

Fortunately, Change Management Software by SimplerQMS makes the change management process much easier.

It allows you to automatically document the change process, create and delegate specific assignments that will be electronically signed when approved, route changes for review and approval, set up reminders, and more.

Management Review of Process Performance and Product Quality

Management review is a comprehensive evaluation of the entire quality management system’s efficiency. This process includes assessing the product, documents, processes, and procedures.

The goal of the management review is to assess whether the QMS is functioning as intended by the company and identify areas for improvement.

The management review could include the following:

• The commitment made to the quality
• Customer complaints
• Nonconformances
• CAPA review
• Audit findings
• Process performance
• Any pending matter or follow-up from previous management review

Management review is essential throughout the whole product lifecycle stages.

During pharmaceutical development, management review should evaluate the adequacy of the product and process design. Meanwhile, during technology transfer, management review should ensure that the product and process design are suitable for commercial-scale manufacturing.

For commercial manufacturing, a structured system for management review must be followed to facilitate continuous improvement. Additionally, management review during product discontinuation should encompass various aspects, including product stability and quality complaints.

Overall, management review is crucial for ensuring the quality and consistency of pharmaceutical products, from development to discontinuation.

SimplerQMS helps in management review by providing a structured approach for evaluating the performance of a pharmaceutical company’s processes and products.

Our system collects and stores data, which can then be used to create pharmaceutical quality KPI reports and trending of key quality metrics.

You can also export all information to create complex data visualizations.

Other processes in FDA regulations, EU GMP, and PIC/S GMP guides outside the product lifecycle that we would like to focus on in this article are:

• Employee training management
• Equipment calibration and maintenance
• Supplier management
• Audit management

Employee Training Management

The pharmaceutical company should provide training for all the personnel whose activities could affect the quality of the product.  

Personnel should receive training on the theory and practice of the Pharmaceutical Quality System and Good Manufacturing Practice, as well as specific training tailored to their job duties. Ongoing training should be provided and periodically evaluated.

Having control of employee training enable you to identify skill gaps, facilitate learning activities, and maintain detailed training records that meet compliance requirements.

SimplerQMS training management module helps companies with a range of features designed to support the training process, including assessments of training effectiveness, tracking of training progress, automated assigning of training activities, automated email notifications, and more.

Equipment Calibration and Maintenance

Equipment calibration and maintenance are critical to ensuring the quality and safety of the products produced in the pharmaceutical industry.

The purpose is to ensure that the equipment used in the manufacturing process is functioning properly and providing accurate and consistent results.

Written procedures are required for calibration, cleaning, and maintenance of equipment used in drug product manufacture. Implementing and following procedures are essential to prevent malfunctions or contamination that could affect the drug product’s safety, identity, strength, quality, or purity.

Using equipment management software by SimplerQMS, pharmaceutical companies can optimize their equipment control processes and easily create maintenance and calibration plans.

It’s possible to develop a list of equipment sorted into categories and to plan and schedule calibration and maintenance activities. You can easily track equipment status, overview ready-to-use equipment, automate notifications for upcoming tasks, as well as link products to equipment.

Supplier Management

Effective supplier management can help ensure a reliable supply chain, minimize the risk of product quality issues, and help pharmaceutical companies comply with regulatory requirements to control materials used in the manufacturing process.

Companies need to have a documented system for selecting, qualifying, and monitoring suppliers of raw materials, packaging materials, and other critical product quality components.

The supplier management process should include a risk-based approach that considers the potential impact on the quality and safety of the finished product.

SimplerQMS offers comprehensive supplier management capabilities to help streamline all supplier-related activities, from qualifying suppliers to maintaining Approved Supplier Lists (ASL), to monitor their subsequent performance.

Audit Management

Self-inspection is an important component of the GMP requirements. Companies should conduct internal audits to monitor the implementation and compliance with GMP principles and to propose necessary corrective measures.

Internal audits should be conducted in a detailed way by assigned competent personnel from the company.

Additionally, independent audits by external experts can also be useful in verifying compliance with GMP requirements.

The audit plan should cover all manufacturing and quality control operations aspects, including facilities, equipment, personnel, materials, production, testing, and documentation. It should also cover any relevant supplier-related processes.

SimplerQMS also provides tools to effectively manage internal audits by proactively identifying and addressing potential quality issues.

Using our audit management module, companies can schedule and plan supplier, regulatory, external, and internal audits, assign responsibilities, and track progress. The system also facilitates maintaining a record of audit findings and actions taken.

Role of Pharmaceutical Quality Management Software

Companies can manage their QMS using manual solutions if the required resources to handle the manual paperwork are available.

However, pharmaceutical quality systems can be complex due to the multiple interlinked processes involved and the high level of documentation required.

The digital revolution in drug manufacturing industries has paved the way for more production with less cost and time. Digital tools can take care of routine processes without compromising product quality, allowing company owners to focus more on innovation and exploring new avenues.

The pharmaceutical industry is already used to digital tools such as Computerized Maintenance Management Systems (CMMS) and Warehouse Management Systems (WMS). These tools effectively streamline processes with a proven track record.

Recently, an increasing number of companies have been opting to implement eQMS. A comprehensive eQMS provides several benefits, including improved workflows, reduced time and costs, cloud-based document storage, automated notifications, and more.

At SimplerQMS, we provide fully validated pharmaceutical quality management software.

Our eQMS not only simplifies employee training and document management but also streamlines change control, CAPA management, deviation management, audits, and many other processes.

Furthermore, to help companies build comprehensive documents, we offer a complimentary template package based on Life Science requirements.

Our software complies with all the relevant regulations and standards, such as FDA 21 CFR Part 11, which sets the guidelines for electronic signatures and electronic records, and EU GMP Annex 11, which provides good manufacturing guidelines for computerized systems.

Additionally, you don’t have to worry about computer system validation. SimplerQMS platform is fully validated according to ISPE GAMP5 and is re-validated upon the creation of a new version or upon applying standard updates.

If you are uncertain about the potential value of investing in an eQMS for your company, we recommend that you explore our eQMS Business Case template – available for download below.

This tool can assist you in evaluating the value of an eQMS for your company and includes the essential material for presenting your findings to the management.

Final Thoughts

Many regulatory requirements regulate the pharmaceutical industry.

The applicable regulatory requirements may vary depending on product type and intended market. Some pharmaceutical requirements include the ISO 9001:2015, ICH Q10, EU and PIC/S GMP, FDA 21 CFR Part 210 and 211.

One of the requirements is to implement a pharmaceutical quality management system and adhere to the processes outlined in it. The QMS enables companies to streamline their quality processes and helps ensure compliance to manufacture safe, efficient, and reliable products.

A digital tool like pharmaceutical QMS software from SimplerQMS helps pharmaceutical companies focus more on problem-solving than routine documentation processes. With our eQMS software, companies can streamline QMS processes to save time and help achieve compliance easier.

Book a free demo to see SimplerQMS Quality Management Software in action and learn how it can help your organization achieve better quality management processes.

The post Pharmaceutical Quality Management System (QMS) appeared first on SimplerQMS.

Let us take the example of metformin (the most commonly used prescription for type 2 diabetes) that your pharmaceutical company is planning to manufacture and sell in a new market. It is only based on regular quality audits that you, the regulatory agencies, and the public, will have the assurance that this product is safe and efficacious for use.

Quality audits can be daunting, but by understanding what will be audited, having accurate documentation, and preparing for questions from the auditor, you can make the process less stressful and more efficient.

This article introduces pharmaceutical audits and offers tips on how to prepare for them.

We will look at the following in more detail:

• What Is a Pharmaceutical Quality Audit?
• Types of Audits in the Pharmaceutical Industry
• Major Pharmaceutical Audits
• Ways in Which Pharmaceutical Audits Are Conducted
• What Does a Pharmaceutical Audit Examine?
• How to Prepare for a Pharmaceutical Audit?
• 10 Tips to Help You Make Auditing Smooth
• Pharmaceutical Audit Management Software Solution

What Is a Pharmaceutical Quality Audit?

A pharmaceutical quality audit is a systematic and independent examination wherein you will establish whether the activities that your company performs are compliant with standard regulations. You will also determine whether they are effectively implemented to achieve the required objectives.

Quality audits, whether internal or external, are essential to a good pharmaceutical quality management system. With the help of quality audits, your pharmaceutical company will effectively evaluate compliance with regulatory requirements and get the required feedback, which is needed for improvement.

With the help of the SimplerQMS audit management software solution, you can significantly reduce the time and effort needed to pass audits by automating audit-related tasks, such as document routing, data collection, notifications, approvals, and escalation of activities.

Types of Audits in the Pharmaceutical Industry

In general, your pharmaceutical company will face three types of quality audits:

• Internal audits
• External audits
• Unannounced audits

Internal Audits

As a pharmaceutical company, you will audit your facilities, systems, and standard operating procedures (SOPs) under a process called internal auditing. These audits are conducted regularly, and you must have procedures and programs available for conducting such audits.

Depending on the complexity of the internal auditing process, it can be categorized into multiple categories:

• Tier 1
• Tier 2
• Tier 3

Using an audit management solution, you can facilitate planned internal audit activities by managing audit schedules, creating regular assignments, setting due dates, and automatically sending out notifications to the right people at the right time.

Tier 1 Internal Audits

These audits are the least complex of the internal audits. They are conducted by personnel of the concerned department or section.

These audits are normally of short duration, are frequent, and concentrate on issues such as auditing the housekeeping or documentation of a particular department or section.

For example, personnel in the manufacturing section may audit the thorough cleaning of all scoops, vessels, and sieves used there.

Even for tier 1 auditing, the personnel assigned to do the auditing need to have received basic training before auditing.

Tier 2 Internal Audits

Tier 2 internal audits are more complex when compared to tier 1 internal audits. They focus more on the system and the frequency is less when compared to tier 1 audits.

For example, this could include auditing the purity of the products developed by the R&D department constitutes a tier 2 example.

These audits, by their nature, will be of longer duration, and the auditors need to have rigorous training with an emphasis on the quality systems and techniques. Also, the auditors will be personnel independent of the concerned department or section.

Tier 3 Internal Audits

Tier 3 internal audits are the most complex and least frequent of the internal audits.

They can be carried out to assess the readiness of the pharmaceutical company for a forthcoming regulatory audit. Additionally, tier 3 internal audits may be conducted before beginning a crucial activity within the company.

For example, if your company is going to start manufacturing metformin for the first time, a tier 3 internal audit is advocated.

The auditors for tier 3 internal audits need to be highly trained with the necessary expertise and knowledge of all regulatory requirements in the pharmaceutical industry.

You can also bring in external consultants to do these types of audits. If you are interested in learning more about how to choose the right consultant, we suggest reading the article on the key areas when selecting a pharmaceutical consultant.

External Audits

External audits are also referred to as second and third-party audits.

Second-Party Audits

Second-party audits are conducted by parties interested in the audited company.

They could be both customers and suppliers.

Supplier audits come under second-party audits because as a manufacturer, you must know your supplier(s) thoroughly.

With integrated audit management capabilities like SimpleQMS you can also manage relevant information derived from supplier audits, and other supplier-related activities such as deviations, non-conformance reports, supplier corrective action requests (SCARs), CAPAs, and quality information in one centralized location.

Recommended Reading: The Simple Guide to Supplier Qualification in Life Sciences

Third-Party Audits

Third-party audits are conducted by external independent organizations, such as notified bodies or authorities.

Regulatory audits conducted by regulatory agencies also come under third-party audits. For example, national regulatory bodies such as the Medicine Control Agencies (MCA) of the UK and the US FDA will mandatorily conduct third-party audits.

In addition, regulatory bodies of one country may audit manufacturers based in other countries. For example, the FDA will audit your manufacturing plant located in Europe, if you are supplying medicines in the US.

It should be highlighted that third-party regulatory inspectors are comprehensively trained and highly knowledgeable.

Unannounced Audits

Manufacturers of pharmaceutical products are subject to random unannounced audits by regulatory agencies. Such audits can also include your third-party vendors who supply crucial raw materials for your products (i.e., unannounced supplier audits).

Such audits are carried out both in the European Union and the US, usually with some months of notice to allow for scheduling and traveling.

The frequency of such audits depends on the complexity of the products that you manufacture and may be anywhere between 3 to 5 years.

Major Pharmaceutical Audits

The major pharmaceutical audits that your company will face can be grouped under internal and external audits.

Major Internal Audits

EU GMPs 1.4 (xvii) states that:

“The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that (xvii) there is a procedure for self inspection and/or quality audit which regularly appraises the effectiveness and applicability of the quality assurance system.”

ICH Q7 D. Internal Audits (Self Inspection) (2.4) states that:

“To verify compliance with the principles of GMP for APIs, regular internal audits should be performed in accordance with an approved schedule. Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. Agreed corrective actions should be completed in a timely and effective manner.”

Your pharmaceutical company should perform regular internal audits in accordance with an approved schedule. These internal audits will check the effectiveness of your QMS and document all audit findings.

If necessary, agreed corrective actions should be completed in a timely and effective manner.

External Audits

EU GMPs 7.5 states that:

“The Contract Giver is responsible for assessing the competence of the Contract Acceptor to carry out successfully the work required and for ensuring by means of the contract that the principles and guidelines of GMP as interpreted in this Guide are followed.”

Before outsourcing to a third-party vendor, your company needs to assess the legality, suitability, and competence of the vendor. You will also ensure that the vendor diligently follows the principles and guidelines of GMP.

Directive 2004/27/EC (19) states that:

“The quality of medicinal products for human use manufactured or available in the Community should be guaranteed by requiring that the active substances used in their composition comply with the principles of good manufacturing practice in relation to those medicinal products. It has proved necessary to reinforce the Community provisions on inspections and to compile a Community register of the results of those inspections.”

Your pharmaceutical company will ensure the quality of the products you manufacture by ensuring that the active substances used in their manufacture and manufactured in accordance with GMP.

SimplerQMS audit management software helps you comply with various regulatory requirements applicable to internal and external quality audits for organizations in the pharmaceutical industry.

Ways in Which Pharmaceutical Audits Are Conducted

There are three ways in which pharmaceutical audits are conducted:

• On-site audits
• Remote audits
• Self-audits

Let’s discuss each one in more detail.

On-Site Audits

As the name suggests, during the on-site audit, the concerned regulatory agencies will come to your company and will review all documents, tour the company’s premises, interview your staff, and verify that your pharmaceutical company meets all regulatory requirements.

Let us look at the example of metformin that your company wants to sell in a new market. The regulatory agency of that country will make an on-site audit and ensure that you have met all necessary regulatory requirements.

Remote Audits

As we know, the COVID-19 pandemic has upended life. It has put a lot of restrictions on both individuals and companies alike. However, one of the plus points has been a renewed interest in remote auditing.

Remote auditing is like on-site auditing regarding the document review, staff interviews, tour of your manufacturing sites, etc. The difference is that the regulatory agency will connect with you virtually using different types of technology.

Your organization will need to use various tools for file sharing, video conferencing, screen sharing, and/or Electronic Quality Management System (eQMS), like SimplerQMS, to share and review the required documents with the regulatory agencies.

To learn more about remote auditing, check out our guide on remote auditing best practices.

Self-Audits

Self-audits are also called internal audits. As discussed before, your pharmaceutical company will conduct internal audits regularly as part of complying with regulatory standards.

These audits are valuable exercises that ensure that the documents and QMS of your company are efficiently and effectively maintained. You should ensure that self-audits are conducted by staff who are not directly involved with the audited matters.

Let us revisit the metformin example. When you start marketing this drug, you will need to conduct regular self-audits to ensure that the medication is manufactured as per documented and planned protocols. This will ensure its safety and efficacy.

What Does a Pharmaceutical Audit Examine?

The quality audits that your pharmaceutical company will undergo will assure the regulatory agencies and public at large that your organization is compliant with all the necessary requirements.

By looking at the typical ways in which audits are conducted, we will get a better understanding of what pharmaceutical audits examine.

On-Site Audits

During on-site audits, some of the typical questions that the regulatory inspectors will ask your company are as follows:

• Do the pharmaceutical facility and the various departments of your company operate under a state of control?
• Does the QA department of your pharmaceutical company review all production records routinely to ensure that protocols and procedures are followed and documented properly?
• Is there sufficient equipment, laboratory space, and qualified personnel on hand?
• Are all QA procedures approved?
• Are all production batch records and release test results first reviewed for completeness and accuracy before the release of a batch of finished products?

Remote Audits

Remote audits are similar to on-site audits, except that they are virtually conducted.

This includes a virtual tour of the entire facility. Other areas/processes that are typically audited during the remote audit include the review of documents, protocols, and policies.

Self-Audits

During the self-auditing process, the personnel selected to conduct this will typically ask the following questions:

• Are the personnel working in the sterile filling area properly trained?
• Are all protocols and procedures up-to-date and authorized?
• Is there any cross-contamination of raw materials or finished products?
• Are the warehouses cleaned according to schedule?
• Are all batch record entries duly filled and signed?

How to Prepare for a Pharmaceutical Audit?

The key points that your pharmaceutical company needs to focus on while preparing for an audit are as follows.

Review All Documents

First of all, you will need to review documents from past audits.

Based on this, you will next need to prepare a detailed list of all relevant documents, including, but not limited to:

• Batch records
• Master formula records
• Standard operation protocols
• Change controls
• Deviations

These documents must be reviewed to ensure that they are validated and current. Also, ensure that all supporting documents and records are available.

It is at this stage wherein an efficient QMS software with robust document control capabilities such as SimplerQMS becomes most useful. All documents are digitized and automatically named, numbered, and versioned, following best practices of pharmaceutical document management. This will help you ensure compliance with the relevant standards and regulations of your industry.

Select Personnel and Delegate Responsibilities

You will need to select one or more individuals from every department as key people for the forthcoming audit.

The responsibilities for the various aspects of the audit will be delegated amongst them.

This personnel will have the requisite knowledge about the auditing, documents, records, systems, and protocols in place.

Prepare an Audit Plan

The third step in your plan of action is for the selected personnel to prepare an audit plan which outlines the flow of the audit.

This plan of action will be provided to the auditing inspectors.

With the SimplerQMS audit management solution, you can group all the upcoming audits under an audit plan and collect all the important details, including title, scope, objective, criteria, auditors, location, and others.

At this point, you need to note the strengths and weaknesses of the various departments. Ensure that the strongest departments are focused first, to highlight the strengths of your company.

Conduct an Internal Audit

The next logical step is to conduct an internal audit.

This will ensure that all relevant personnel is confident and that any loopholes are fixed. You may consider bringing in external experts for this part of the auditing process.

Be Prepared for Remote Audits

The COVID-19 pandemic has shown that remote auditing is here to stay.

Be prepared for remote auditing with file sharing, video conferencing, screen sharing, and an efficient eQMS solution.

10 Tips to Help You Make Auditing Smooth

Pharmaceutical Audit Management Software Solution

If your pharmaceutical company is still using paper-based systems and processes, there are limitations and challenges that you are likely to face regularly.

Recording on paper-based systems is a lengthy process. At times, the information may no longer be relevant at the time it is transcribed.

Documentation errors can lead to regulatory non-compliance. This can prove to be costly for the company in terms of brand name, time, and money.

With the help of the SimplerQMS audit management software solution, you will save the time and effort that is needed to successfully pass your audits.

The system automates audit-related activities so that you can reduce the time and effort needed to successfully pass audits.

With SimplerQMS, you can easily collect documents and reports across the product life cycle, in a single location. This makes it easy to share information with external partners. The system also allows you to easily link a response such as a nonconformance, supplier corrective action request (SCAR), or CAPA. This makes it easy to track and resolve quality issues.

Final Thoughts

Quality audits in the pharmaceutical industry are essential to ensure compliance with regulatory requirements and give confidence to the public that your products are of the best quality and efficacy.

When you invest in an efficient eQMS such as SimplerQMS, you will save both time and effort with the entire auditing process. You will find that it’s much easier to ensure regulatory complaince and will benefit from a host of other features.

Book a demo today and talk to our experts to see how we can help you streamline your audit management process and help you work more efficiently with your documentation.

The post Guide to Quality Audits in the Pharmaceutical Industry appeared first on SimplerQMS.

The CAPA process plays an important role in the quality management system of any pharmaceutical company. It helps to identify, evaluate, prioritize and manage nonconformities or problems related to products or processes to prevent them from recurring.

This article aims at providing readers with information on what CAPA is all about and how they can successfully implement an effective CAPA system in a pharmaceutical organization.

Here’s what we will discuss:

• What Is CAPA?
• What Should Trigger CAPA?
• The Importance of a CAPA Process in the Pharmaceutical Industry
• CAPA Requirement
• Steps of CAPA Process
• Common Challenges With CAPA
• Tips for Effective CAPA Implementation
• Digitizing CAPA Management Processes

What is CAPA?

CAPA stands for Corrective Action and Preventive Action, a system for analyzing, correcting, and preventing issues. It outlines procedures to solve the issue, it also analyzes the cause of the problem to prevent its recurrence.

For example, Corrective Action and Preventive Action (CAPA) can investigate the misprinting problem in a pharmaceutical manufacturing environment. The CAPA initially proposes corrective actions to solve the misprinting problem and then investigates the cause to prevent recurrence in the future.

What Should Trigger CAPA?

Not every deviation or nonconformance requires a CAPA.

An unnecessary CAPA can result in additional costs, processes slowdowns, and inefficient usage of the organization’s resources. It also becomes difficult for the team to follow up, resulting in an uncompleted pile of CAPA’s.

Conversely, uncompleted CAPA’s can be a serious compliance problem.

There are certain situations, that when they occur, can trigger a CAPA.

Nonconformances or Deviations

Non-conformance or deviation is the failure to fulfill the associated requirements and can occur both in products and processes. Non-conformance can also result due to an inability to meet the requirements of a customer. It can be identified during the manufacturing process or if a defective product is returned to the manufacturer.

For example, manufacturing requires a specific temperature for carrying out a specific process. However, quality personnel detects the temperature deviation and find out that this deviation is occurring for a very long time. This problem is a non-conformity and triggers a CAPA.

Recommended Reading:

• What Is Non-Conformance And How to Minimize It
• Guide to Deviation Management Process

Customer Complaints

Customer complaints help identify product deficiencies after it is released to the market.

The communication mode can be written, oral, or electronic. The defect can indicate a product’s inability to fulfill its desired effectiveness, quality, results, or performance.

Every manufacturer must maintain a complaint handling system for receiving, reviewing, and evaluating complaints. The manufacturer is also responsible for processing the complaints promptly, documenting complaint reviews and investigations as well as sharing information across relevant departments and regulatory bodies.

For instance, if a pharmaceutical manufacturer receives a complaint of an empty pocket in a tablet blister pack, it should trigger a CAPA.

Audit Findings

The main objective of the pharmaceutical audits is to inspect whether the existing quality system is in line with the established quality system requirements.

There are two types of audits – internal and external audits.

An internal audit is performed by a team of the same manufacturing organization. However, they must be from another department and should not be interested in the department being audited.

On the other hand, external regulatory and standardization organizations perform external audits.

For example, if during an audit, particles are found in injectables filling operation, it will result in non-conformance. Since this is a serious issue, it would require a CAPA.

Using an efficient CAPA management software like SimpleQMS you can quickly initiate forms from various deviations, non-conformances, customer complaints, audit findings, and other issues.

The Importance of a CAPA Process in the Pharmaceutical Industry

CAPA is a resource-intensive activity, and as we discuss, in some cases it can be considered unnecessary.

However, a properly established CAPA process can be an excellent tool for achieving an organization’s quality goals in the following manner.

Regulatory Compliance

CAPA is a compliance requirement for different regulatory agencies,such as the FDA. For example, if during the FDA inspection an auditor finds any cGMP violations, the accredited manufacturers should implement appropriate Corrective Actions and Preventive Actions (CAPA’s). The FDA issues the warning letter if the pharma manufacturer fails to execute necessary Corrective Actions and Preventive Actions (CAPA’s).

Proper CAPA process in a pharmaceutical’s maintenance department can help to keep their maintenance strategies, process flow, and documentation procedures according to guidelines of standardization bodies.

Successful Audits

cGMP violations in pharma manufacturing are not uncommon and can occur due to reasons such as Human Negligence and Environmental factors. During their audit and inspection, Regulatory bodies pay special attention to the organization’s approach towards mitigating risks and improving quality throughout the entire product life cycle. One of many ways is the implementation of a proper CAPA system.

Executing the Corrective Actions and Preventive Actions (CAPA’s) on time helps keep the organization audit-ready. The CAPA must be appropriately carried out, documented, maintained, and produced at the time of audits and inspections.

Cost Savings

One of the main advantages of CAPA is cost-saving, resulting in efficient output with optimum quality.

It also creates reliability in their processes, systems, and products, which could result in increased revenue for a pharmaceutical manufacturer.

In the beginning, it might be costly to establish a CAPA process, but as time advances and the process itself improves, it eliminates the recurring problem and results in improved process performance with minimum downtime and reduced failures.

Overall Efficiency

CAPA increases the efficiency of the processes and systems, as an effective CAPA reduces overall operational costs. The cost-saving can then help promote innovation and improvement in the product.

Improved efficiency can also increase market share by offering cost-effective, quality products to compete with the competitors.

One effective way of improving cost and efficiency is using a digital CAPA management software solution. With SimplerQMS CAPA software, personnel is more focused on executing the process rather than planning, following up, and preparing for audits and inspections.

Improved Product Quality

CAPA is a process improvement system that increases product quality. It includes identifying and investigating product problems and obliging manufacturers to prevent their recurrence. It also enables the manufacturer to study the implemented action plan’s effects and monitor the effectiveness of proposed corrective and preventive actions.

If these activities are carried out regularly, it significantly increases the product quality and lowers product failure.

CAPA Requirements

Let’s look at some of the regulatory requirements regarding CAPA.

ICH Q10 Pharmaceutical Quality System

ICH Q10 is harmonized model for pharma manufacturers to implement a Quality System. It is based on existing models such as cGMP and does not create an alternate model regarding quality requirements. The ICH Q10 considers CAPA as one of four Pharmaceutical Quality System elements.

The ICH Q10 pharmaceutical quality system guidelines require manufacturers to implement a CAPA system for handling complaints, product rejections, nonconformances, and recalls.

The FDA cGMP requirements can be summarized below:

• CAPA procedures must be well-defined and documented
• Appropriate sources of product and quality problems must be identified
• Product and quality information that may show unfavorable trends should be identified
• It is important to verify that the data received by the CAPA system are complete, accurate, and timely
• You must verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems
• Failure investigation procedures must be followed
• Appropriate actions should be taken for significant product and quality problems identification from data sources
• Corrective and preventive actions should be effective and verified or validated before implementation
• You must verify that corrective and preventive actions for product and quality problems are implemented and documented
• Information regarding nonconforming product and quality problems and corrective and preventive actions must be properly disseminated, including dissemination for management review

ISO 9000:2015

The ISO is a standardization body that develops standards, including the Quality Management System (QMS). The QMS focuses on product quality, and the CAPA is a module within a comprehensive QMS.

According to ISO 9000:2015, the pharmaceutical manufacturer is responsible for taking action and controlling the nonconformities. It also requires the manufacturer to eliminate the cause of the nonconformity by:

• Reviewing and analyzing the nonconformity;
• Determining the causes of the nonconformity;
• Determining if similar nonconformities exist, or could potentially occur;

Similar to the FDA requirements, the manufacturer is responsible for implementing corrective actions, reviewing the effectiveness of disciplinary action, analyzing risks and opportunities, and any change for process improvement.

Moreover, the manufacturer should always retain documented evidence of non-conformities and corrective actions.

Steps of CAPA Process

Let’s go through the seven steps of a CAPA implementation process.

Identification

Problem identification is the first step and plays a vital role in the success of the ongoing CAPA process. It includes identifying all the product and quality problems that require corrective actions. It also provides identification of sources used to classify issues such as complaints, returned product records, quality audits, installation reports, lawsuits, and non-conforming products.

Evaluation

In this stage, the problem is evaluated for further decision-making.

The problem is analyzed to determine its nature and whether it requires a CAPA or not? It also considers its impact on other processes and its effect on the output.

It also analyzes the severity of the problem.

For example, suppose a lack of safety is identified on the machine during an audit. In that case, it can be evaluated for different severity levels and how it impacts the machine operation and operator safety.

Investigation

In this step, the problem is investigated for further planning.

The typical investigation includes objectives, i.e., deliverables, Procedures delivering the intent of the action, and Personnel for conducting the investigation. The root cause should be documented for better understanding and implementation.

For example, a team leader’s responsibilities can include authorization to use departmental resources and interviewing the concerned personnel to fully understand the problem.

Analysis

This step identifies and establishes the root cause of the problem by investigating the available data. The required information must be accurately depicted and preserved to reflect the actual cause of the problem.

Action Plan

This step’s success depends on the success of the preceding steps.

It is a series of steps required to implement corrective and preventive actions.

For example, it might include employee training if the CAPA team concludes that the cause of the problem was the inability of the personnel to use the system.

Implementation

It is about how the action plan is implemented, devised in the previous stage.

It includes detailed information about the action plan, desired outcomes, settings, steps, and observation. The final action plan must be thoroughly documented for record purposes.

For example, if the training plan is the action plan, implementation of the training could include devising training contents, arranging training resources, instructor, and so on.

Follow Up

After the team executes the CAPA activity, they must follow up.

It helps to measure the effectiveness of the Corrective and Preventive actions and improves the remedial measures.

After this stage, the CAPA activity is finally concluded with a detailed CAPA report.

For example, the training plan is the suggested solution. In that case, follow-up could include assessing the participant’s capabilities, whether more training is required or not, and marking participants as pass or fail.

Using QMS software with a built-in training management software solution you can assure efficient, well-documented, and compliant training management. With SimplerQMS, you can ensure that all employees receive the correct training based on their functional roles. Automatic notifications and reminders ensure that everyone is kept up to date with new trainable procedures, instructions, documents, and videos.

Common Challenges With CAPA

Many pharmaceutical manufacturers face challenges when implementing Corrective Actions and Preventive Actions (CAPA’s).

Because every manufacturer wants to focus on production, and during production, cGMP violations are not uncommon. These violations demand Corrective and Preventive Actions, thus most manufacturers found CAPA one of the primary compliance pain points.

In-Efficient Root Cause Analysis

The CAPA is all about Root Cause Analysis (RCA) to investigate and pinpoint the problem cause. If it does not process in the right direction, the entire CAPA will have inefficient solutions and wastage of resources. It could result in corrective actions that address the same event repeatedly.

There are many reasons for an inefficient Root Cause Analysis (RCA), for example:

• The inability of the CAPA team to identify, and categorize the problem
• Lack of a tool for CAPA processing like CAPA management software
• Not giving importance to RCA and instead of treating it as a compliance requirement

Manual CAPA Processing

Most pharma manufacturers still use manual paper/spreadsheet-based systems to process their CAPA’s. This creates challenges for pharma manufacturers to maintain consistency and comply with the regulatory requirements regarding a CAPA system.

Without a dedicated document control solution, pharma manufacturers can face de-centralized documents, manual chasing for signatures, overlapping responsibilities, and most importantly, missing due dates in implementing CAPA.

This can also result in overused CAPA or underused CAPA. This means initiating CAPA for the issues that do not require CAPA while missing the critical conformities requiring corrective and preventive actions.

Lack of Adequate Documentation

Quality compliance requires the pharmaceutical manufacturers to document all the processes correctly, and the same is the case with CAPA’s.

Every step, process, and outcome should be reported.

The documentation format should be pre-approved before the execution of the CAPA activity. The regulatory bodies during an audit and inspection purposefully check the documentation for consistent CAPA activity.

Tips for Effective CAPA Implementation

Effectively implementing CAPA is necessary to create practical corrective and preventive actions. Otherwise, it can result in a wastage of resources.

Some tips for effective CAPA implementation are mentioned below.

Approved Process

The CAPA activity should be carried out as per the approved process. The approval must be taken from all the stakeholders, such as the Quality department, production, and maintenance department. After approval, the document must be controlled, and a copy to be retained in all the concerned departments.

This is often called a CAPA procedure.

Additionally, there must also be a CAPA form. The CAPA form is an approved format, which helps initiate a CAPA for process improvements.

Typical CAPA form includes:

• Detailed problem description
• Root Cause associated with the problem
• Corrective actions proposed to solve the problem
• Preventive actions proposed to prevent recurring
• Approval and Signatures from the concerned department, and personnel involved in the CAPA process

Keep Data Centralized

Secure data storage, access controls are key to any process, and timely data availability is vital to the success of any CAPA activity.

Therefore, it is recommended to consider implementing a document control software system like SimplerQMS that stores the data in centralized and secure cloud storage and makes it readily available at any time, from anywhere.

Document Non-Conformities and Feedback

Recording all non-conformities and feedback helps CAPA keep on track, in line with main objectives. Because, during CAPA, there can be many input variables which can be sometimes relevant, and sometimes not. Recording all the information makes it possible to analyze during the decision-making step.

For example, the information required during the identification stage should be thoroughly filled, including problems and their sources.

Risk-Based Approach

It is recommended to execute CAPA by utilizing a risk-based approach. The risk-based approach allows assessing risks associated with non-conformity under observation. The outcome of the CAPA is treated as a risk, with its appropriate severity level.

For example, if a department fails to show a control copy of the Job Description for any of its personnel, this shortcoming can be categorized as Low, Medium, or High risk, according to the acceptance criteria.

Simple Problem Definition

Problem definition or presentation should be simple, aimed at ordinary personnel with basic process understanding.

This helps to quickly and easily understand the problem without confusion. Simple problem definition leads to effective and accurate solutions, resulting in better process improvement and quality.

Digitizing CAPA Management Processes

Manual, paper-based documentation processes have several drawbacks, including a lack of visibility, incomplete documents, missing signatures, and so on.

Modern eQMS solution with powerful CAPA management capabilities like SimplerQMS allows you to digitize and automate a bulk of routine CAPA processes in a pharmaceutical organization. Such as document routing, notifications, task reminders, escalation, and approvals. This allows you to accelerate issue resolution and ensure regulatory compliance.

SimplerQMS integrates the CAPA system with the core quality management system (QMS) providing you enterprise-wide visibility.

Furthermore, you can use pre-configured forms to quickly initiate forms from nonconformances, customer complaints, audit findings, and more. With visibility into all quality processes, you can analyze data identify patterns, and address areas of concern before they become a reality.

Final Thoughts

Pharmaceutical companies are required to maintain a quality management system that ensures the safety, efficacy, and quality of products. It is therefore important for pharmaceutical organizations to implement CAPA systems in their operations.

The article has touched upon some of the major aspects that need to be considered when designing and implementing a CAPA system. Pharmaceutical organizations must have an effective CAPA process in place, which can help them avoid risks such as product recalls or loss of customer trust.

If you are looking for a powerful eQMS solution with robust CAPA management capabilities, feel free to get in touch with our experts by booking a demo today!

The post What is CAPA in the Pharmaceutical Industry? appeared first on SimplerQMS.