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.
Annex 1 - Design & Build
The new EU GMP 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 preventing contamination.
Annex 1 - Qualification
There has been a significant change to the guidance for initial qualification in Annex 1. Previously, qualification was recommended to be completed to the ISO 14644 series of standards. Now, Annex 1 details the testing that is expected in the initial qualification, then what is needed as part of the requalification.
Annex 1 - Requalification
The requalification of cleanrooms and clean air equipment should be carried out periodically following defined procedures. For Grade A & B areas, the maximum time interval for requalification is 6 months. For Grade C & D areas, the maximum time interval for requalification is 12 months.
Annex 1 - 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.
Have you met our in-house GMP team?
Joan Benson
Global compliance and quality assurance manager
Joan has 30 years previous experience in Cell and Gene Therapy, Academia, Pharmaceutical Industry, Contract Clinical Research and Hospital Aseptic facilities. She was front facing regulatory inspections in MHRA, FDA, HTA and HFEA for 20 years.
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