Examining Contamination Control Strategy in Primary Packaging as Part of EU GMP Annex 1

There are two major themes that involve primary packaging components in the revised EU GMP Annex 1 issued in August 2023. This recent revision includes:_x000D_ _x000D_ 1. Implementing a holistic Contamination Control Strategy (CCS) _x000D_ _x000D_ 2. Container Closure Integrity (CCI) because a properly seated stopper represents an adequate microbiological barrier. _x000D_ _x000D_ Pharmaceutical manufacturers must develop a CCS detailing the risks and mitigations within their operations, associated with contamination event opportunities with the emphasis being on personnel awareness, quality culture and controls, with focus on the principles involved in the protection of sterile product during the manufacturing, packaging and distribution processes._x000D_ _x000D_ _x000D_ This is why it is important to consider packaging decisions early in the development process. We will examine how primary packaging materials can impact your CCS and showcase West’s approach to mitigating risk on behalf of drug developers.