This blog is a summary of the key changes of relevance to primary packaging components seen in the latest iteration of EU GMP Annex 1.
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.
Topics
- Analytical and bioanalysis
- Bioprocessing and biomanufacturing
- Controlled release and advanced delivery
- Drug Development
- Drug-device combination products
- Formulation and drug delivery
- GMP and quality management systems (QMS)
- Packaging, containers and labelling
- Parenterals and sterile injectables
- Regulation and compliance
- West Pharmaceutical Services
