Current Good Manufacturing Practices (cGMPs) are a set of regulations that aim to ensure the quality and safety of products manufactured for human and animal use. The cGMPs are enforced by the Food and Drug Administration (FDA) and apply to companies operating in the...
FDA 21 CFR Part 11 and EU GMP Annex 11 address similar concerns and aim to achieve the same goals, namely data integrity, comprehensive audit trails, limited system access, trained users, and more. However, there are notable differences between these regulations....
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...
EU Annex 11 outlines requirements for using computerized systems in the Life Science industries operating within the European Union. It is a guidance document for interpreting the principles of good manufacturing practice (GMP) for medicinal products. In this article,...
The European Union In Vitro Diagnostic Regulation (EU IVDR) is the European law concerning placing in vitro diagnostic medical devices for human use and their accessories on the market. The IVDR was introduced in May 2017 to improve the safety and efficacy of in vitro...
Good Manufacturing Practices (GMP) is a part of the Quality Management System that helps ensure products are produced and controlled according to quality requirements. Companies must ensure that all procedures impacting the product’s identity, strength, quality,...
