Manufacture of Sterile Medicinal Products
Revised Annex 1 introduces the mandatory Contamination Control Strategy (CCS) as a holistic document integrating all contamination prevention measures across site, facility, equipment, personnel, and processes. It is among the most comprehensive revisions in the document's history.
All manufacturers of sterile medicinal products for human and veterinary use operating under EU GMP. Also adopted by PIC/S member states globally.
- 01Contamination Control Strategy (CCS) as a site-level document linking all contamination controls
- 02RABS or isolator technology for all new sterile manufacturing facilities
- 03Documented justification for any Grade A area that does not use a barrier system
- 04Glove integrity testing — frequency and methods must be documented in CCS
- 05Environmental monitoring trending with defined alert/action levels and investigation procedures
- 06Personnel monitoring at specific anatomical sites with frequency based on risk
- 07Media fill programme covering all operators, shifts, and critical interventions
August 2022 full revision replacing 2003 version. Major changes: mandatory CCS, barrier technology preference, glove integrity, expanded environmental monitoring requirements, new media fill requirements.
EU GMP Annex 1 (2022): frequently asked questions
Quick answers to common questions about EU GMP Annex 1 (2022).
What is EU GMP Annex 1 (2022)?
EU GMP Annex 1 (2022) — Manufacture of Sterile Medicinal Products — is a regulation issued by the European Medicines Agency (European Union). Revised Annex 1 introduces the mandatory Contamination Control Strategy (CCS) as a holistic document integrating all contamination prevention measures across site, facility, equipment, personnel, and processes. It is among the most comprehensive revisions in the document's history.
Who does EU GMP Annex 1 (2022) apply to?
All manufacturers of sterile medicinal products for human and veterinary use operating under EU GMP. Also adopted by PIC/S member states globally.
What are the key requirements of EU GMP Annex 1 (2022)?
EMA EU GMP Annex 1 (2022) requires, among other things: Contamination Control Strategy (CCS) as a site-level document linking all contamination controls; RABS or isolator technology for all new sterile manufacturing facilities; Documented justification for any Grade A area that does not use a barrier system; Glove integrity testing — frequency and methods must be documented in CCS.
When was EU GMP Annex 1 (2022) last updated?
The current version of EU GMP Annex 1 (2022) dates from August 2022. August 2022 full revision replacing 2003 version. Major changes: mandatory CCS, barrier technology preference, glove integrity, expanded environmental monitoring requirements, new media fill requirements.
Ready-to-use templates designed to help you comply with EU GMP Annex 1 (2022).
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