Are we set for the revised EU GMP Annex 1?
Posted: 23 August 2024 | | 2 comments
This blog is a summary of the key changes of relevance to primary packaging components
EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.1 It provides specific requirements for the manufacture of sterile medicinal products, including principles for cleanroom and clean zone design, personnel experience/qualification, and monitoring of manufacturing environments, just to name a few. The objective is to ensure product quality and potency, as well as patient safety, by minimizing risks of microbial, particulate and endotoxin/pyrogen contamination through manufacturing and environmental controls.
In this blog, a summary of the key changes of relevance to primary packaging components and how West can help with the implementation will be discussed.
Related topics
Analytical techniques, Biologics, Biopharmaceuticals, Drug Delivery Systems, Drug Development, Good Manufacturing Practice (GMP), Manufacturing, Medical Devices, Packaging, Regulation & Legislation, Vaccines
Thxs for this condense of annex 1
What ongoing steps should manufacturers take to stay informed about regulatory changes and maintain compliance?