West Case Study Meeting Annex 1 Regulations

This case study outlines how a European contract manufacturing organization (CMO) proactively responded to the revised EU GMP Annex 1 regulations, which introduced stricter requirements for sterile drug packaging, contamination control, and quality assurance. Faced with the challenge of selecting the right stopper quality for a diverse customer base while ensuring regulatory compliance, the CMO needed to improve particulate specifications and demonstrate a phased contamination control strategy aligned with Annex 1 expectations.