Annex 1
EU GMP Annex 1 — Manufacture of Sterile Medicinal Products · eu gmp annex 1 · sterile manufacturing annex
EU GMP chapter governing sterile drug manufacture — contamination control strategy, grades A–D cleanrooms, aseptic process simulation, and PUPSIT.
Annex 1 of the EU GMP guide is the rulebook for manufacturing sterile medicinal products. The 2022 revision made the Contamination Control Strategy (CCS) mandatory, formalised Grades A–D cleanroom classification, tightened expectations on barrier technology (RABS/isolators), aseptic process simulation (media fills), environmental monitoring, and pre-use post-sterilization integrity testing (PUPSIT) of sterilising filters.
In V5 the CCS is a living document linked to every cleanroom qualification, EM trend, deviation, and CAPA, so an inspector can pull the chain from policy to evidence in one view.
- EU GMP Annex 1 (2022)
Free trial, no credit card, onboard in days, not months.