What is EU GMP Annex 1?
Annex 1 of EU Good Manufacturing Practice (GMP) provides specific guidance on the manufacture of sterile medicinal products. The draft was launched in 2018 and the new revision was released on 25th August 2022. Even before its release, the new approach of using of a quality risk management (QRM) and a facility-wide contamination control strategy (CCS) had already begun to be adopted in the industry.
Now the draft has become live, C2C is ready for implementation of EU GMP Annex 1 to keep our clients compliant.
Are you ready for EU GMP Annex 1?
What are the major changes?
The new Annex 1 requirements focus on eliminating the risk of product contamination during the manufacturing process and when the completed product leaves the cleanroom environment. This is all about driving high standards in sterile pharmaceutical manufacturing and protecting patients from any potential ill effects of contamination.
The principles of Quality Risk Management (QRM) and Contamination Control Strategy (CCS) are introduced.
Initial qualification & requalification
There has been a significant change to the guidance for validations and requalification in EU GMP Annex 1. Previously, validation was recommended to be completed to ISO 14644-1. Now, EU GMP Annex 1 details the testing that is expected in the initial qualification, then what is needed as part of the requalification.
Design & build
The previous Annex 1 has 16 pages and 127 clauses. The newly released Annex 1 has 58 pages and 295 clauses, providing a much more thorough insight into what is expected when manufacturing a sterile product. There have been some significant changes to the guidance for cleanroom construction materials, transfer protocol, airlocks, pressure differentials, and more.
Consumables & equipment
Annex 1 includes guidance on furniture, rotational cleaning, sterile products, product transfer and gowning. Read our guide to find out how to keep compliant.