Glossary · GxP: good practices
EU GMP Annex 1 (sterile medicinal products)
Also known as: Annex 1, EU GMP Annex 1, Manufacture of Sterile Medicinal Products
EU GMP Annex 1 is the annex of EudraLex Volume 4 on the manufacture of sterile medicinal products. Its revised version of 2022 applies since August 25, 2023 (one point on lyophilizers since August 25, 2024) and requires, among other things, a site-wide contamination control strategy (CCS) based on quality risk management.
- GxP
- Pharma
- EU
In one sentence
EU GMP Annex 1 governs sterile medicine manufacturing; the 2022 revision applies since August 2023 and requires a contamination control strategy.
Example
A fill-finish site writes a contamination control strategy that links its isolator design, cleanroom grades, gowning, disinfection, environmental monitoring and sterile filtration controls, and reviews it when trend data change.
How it applies
- Contamination control strategy: The CCS is a documented, site-wide strategy covering design, procedures, personnel, utilities, monitoring and their interplay. It must be reviewed and kept current.
- Cleanroom grades: Annex 1 defines grades A to D with limits for airborne particles and microbial contamination, in operation and at rest. Classification uses the methods of ISO 14644-1.
- Technology: The revision emphasizes barrier technologies such as isolators and restricted access barrier systems, and quality risk management under ICH Q9(R1) as the basis for decisions.
- Sterilization and aseptic processing: Sterilization processes are validated; aseptic processes are verified by process simulation (media fills).
- Technical documentation: The CCS, cleanroom qualification reports, environmental monitoring data and media fill records are the core evidence inspectors review.
Annex 1 grades vs. ISO classes
ISO 14644-1 classifies cleanrooms by airborne particle concentration only, in ISO Class 1–9. Annex 1 grades A to D add microbial limits and define limits for both the at-rest and in-operation states. The two are related but not identical: a room meeting an ISO class does not by that alone meet a GMP grade.