Update Breakdown
2023 Changes to EU Annex 1
The latest changes to EU Annex 1 go into effect August 25th. EU Annex 1 is designed to outline the requirements for the manufacture of sterile medicinal products.
Key changes:
- A Contamination Control Strategy (CCS) is now required and should be implemented across the facility
- Contaminants should be now removed before performing disinfecting. Sterile Wipes can be used for this task
- More than one type of agent is now required for disinfecting activities.
- Disinfectants and detergents used in grade A and grade B areas should be sterile prior to use
- Facility suits (cleanroom coveralls), covering the full length of the arms and the legs, and (cleanroom) socks covering the feet, should be worn before entry to change rooms for Grades B and C areas
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