The revision of Annex 1 (Eudralex Volume 4) was published August 2022. This has been accompanied by numerous clarifications and extensions to the requirements for the manufacture of sterile medicinal products. These entail considerable additional effort for the companies concerned and require adjustments to existing plants and equipment as well as to established processes.
This topic is the subject of the technical article by gempex:
Raimund Brett, Daniel Kapp, GMP PharmaCongress/pharmind 02-2026: "Implementation of Annex 1 – Helpful information from practice"
The technical article was published in the accompanying journal to the GMP PharmaCongress 2026 and first disclosed in pharmind 02/2026.
In the technical article, the authors share experiences gained in their daily consulting work and in the implementation of EU GMP Annex 1 in sterile production over the last three years. In-depth aspects include:
- Contamination control strategy
- Adaptations to a conventional cleanroom
- 100% leak testing of containers sealed by fusion
- Pre-Use Post Sterilization Integrity Test (PUPSIT): Theory and practice
The technical article is available for download at www.gempex.de/GMP-knowledge.
The authors Raimund Brett, Principal Consultant at gempex GmbH, and Daniel Kapp, Consultant at gempex GmbH, are available for questions on the implementation of Annex 1 at contact@gempex.com.
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