West Pharma

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.

This article answers key questions about the revised EU GMP Annex 1, which sets stricter standards for sterile drug manufacturing, including contamination control strategies, personnel training, and the use of modern barrier technologies like RABS and isolators. It explains the rationale behind the revision, its impact on both new and marketed drugs, and how manufacturers must adapt to meet heightened regulatory expectations.

Manufacturers of sterile medicinal productEntire supply chain s entered a new era with the August 2023 EU GMP Annex 1 updates, all of which ultimately focus on enhanced public health protection. This article outlines the pharmaceutical manufacturers requirements to develop a comprehensive contamination control strategy that documents their assurance of sterile drug quality and patient safety

This whitepaper by West Pharmaceutical Services explores how pharmaceutical manufacturers and suppliers can confidently navigate the revised EU GMP Annex 1 guidelines for sterile drug production. It outlines the challenges posed by the new requirements—especially around implementing a robust contamination control strategy (CCS)—and shares West’s proactive, data-driven approach to compliance.

This whitepaper provides a comprehensive overview of how pharmaceutical manufacturers can achieve compliance with the revised EU GMP Annex 1 regulations, which mark a significant shift in the standards for sterile medicinal product manufacturing. Particular emphasis is on a holistic, risk-based approach to contamination control across the entire supply chain.

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