The 2024 EU GMP Annex 1 Revision: A Technical Roadmap for Holistic Contamination Control and Quality Risk Management in Sterile Manufacturing
This review discusses the 2024 revision of EU GMP Annex 1, focusing on contamination control and quality risk management in sterile manufacturing.
- Publisher
- International Journal of Pharmaceutical Sciences
- Published
- Length
- 15 pages
- File
- 4.2 MB PDF
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# Executive Summary
This whitepaper reviews the 2024 revision of EU GMP Annex 1, emphasizing a holistic approach to contamination control in sterile manufacturing. Key findings include:
- Transition from prescriptive compliance to a risk-based framework centered on Quality Risk Management (QRM).
- Mandatory implementation of a site-wide Contamination Control Strategy (CCS) to ensure sterility assurance.
- Adoption of advanced barrier technologies and absolute zero-CFU expectations in Grade A zones.
- Identification of significant operational and economic challenges for legacy facilities and small-to-medium manufacturers.
- Insights for regulators and quality professionals navigating compliance with the revised standards.
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