The updated version of EU GMP Annex 1 was first published on 25th August 2022 and will be implemented on 25th August 2023.
Annex 1 Update Summary:
- 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 are ideal 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
- Sterile eye coverings (sterile goggles) and sterile facemasks are worn to cover and enclose all facial skin and prevent the shedding of droplets and particles
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