The deviation management process is a systematic approach to identifying, analyzing, solving, and documenting events that deviate from the established protocols during the development, manufacturing, and commercialization of products. It is an important part of...
Change control in the pharmaceutical industry is a systematic approach to managing product, process, or system changes. 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...
Standard Operating Procedure (SOP) is a document that provides directions on how tasks and processes should be carried out within a company. Standard Operating Procedures (SOPs) are an integral part of the routine operations in the pharmaceutical industry, and every...
The ICH Q10 Pharmaceutical Quality System (PQS) is a guideline that outlines a model for an effective quality management system for the pharmaceutical industry. ICH Q10 provides a comprehensive model based on the International Standards Organization (ISO) quality...
Pharmaceutical Quality Management System (QMS) is a set of procedures and practices contributing to product quality. The QMS must reflect the relevant regulatory requirements applicable to the industry and company. In the pharmaceutical industry, some of the important...
Quality audits are crucial to ensure compliance with regulatory requirements in any industry. Similarly, quality audits are conducted in the pharmaceutical industry to ensure that the complex system of processes and operations of your pharmaceutical company meets...
