Achieving EU GMP Annex 1 Compliance Through An End-To-End Approach To Contamination Control

By Dr. Ana Kuschel, Principal, Scientific Affairs

The landscape of sterile drug manufacturing in the European Union shifted dramatically on August 25, 2023. The revised EU GMP Annex 1, focusing on Good Manufacturing Practice, introduced a new era of stringent standards, impacting pharmaceutical companies and their global supply chains.

This date marks a pivotal moment, as the updated Annex 1 mandates a complete overhaul of sterile manufacturing practices. The core objective is to minimize contamination risks—microbial, particulate, and endotoxin/pyrogen—thereby safeguarding patient safety and reducing product recalls. Achieving this requires a holistic approach, demanding meticulous control over every aspect of the manufacturing process.

Key changes emphasize the critical role of primary packaging, particularly Container Closure Integrity (CCI), and the implementation of a robust, evidence-based Contamination Control Strategy (CCS). Manufacturers are encouraged to embrace innovation and enhance their processes to meet these new requirements.

West has proactively prepared for these changes, recognizing their broad scope and significant impact. We understand the challenges our partners face and have focused on strengthening our CCS to support their compliance. This article highlights three crucial areas where West has taken action to ensure our customers can navigate the revised Annex 1 effectively.