03.26.25 -- Revised EU GMP Annex 1: Your Compliance Guide

The revised Good Manufacturing Practice (GMP) Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, aiming to minimize contamination and ensure patient safety. These changes apply to both new and existing marketed drugs, addressing concerns highlighted by FDA recall data related to particulate contamination and lack of sterility.

Review the implementation of a holistic Contamination Control Strategy (CCS) and increased emphasis on Container Closure Integrity (CCI). Specifically, explore the importance of a CCS, how it formalizes contamination control efforts, and West's role in supporting manufacturers' compliance. Discover four key considerations for assessing component readiness: product, process, protection, and proof.

With the introduction of the updated Annex 1 regulations, the sterile manufacturing supply chain entered a new era which requires a more holistic, consistent, and ever-improving approach to contamination control. Review three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.

A large European CMO produces multiple biologic drugs, across many therapeutic areas, for a broad portfolio of customers. The CMO assessed the market relating to component qualities, product specifications, and manufacturer process controls to help them decide what stopper quality to suggest to their customers, which serviced the need for regulatory compliance for products sold into the EU.

Gain insights pertinent to efficient and effective drug development. A critical success factor to a Contamination Control Strategy (CCS) is the ability of your suppliers to create and maintain a holistic approach. Learn how West addresses EU GMP Annex 1 requirements through the implementation of a comprehensive CCS across its global network to ensure best practices and continual improvement.