Update Summary

EU GMP Annex 1 2023 Updates

The updated version of EU GMP Annex 1 was first published on 25th August 2022 and will be implemented on 25th August 2023.

1. A Contamination Control Strategy (CCS) is now required and should be implemented across the facility
2. Contaminants should be now removed before performing disinfecting. Sterile Wipes are ideal for this task
3. More than one type of agent is now required for disinfecting activities.
4. Disinfectants and detergents used in grade A and grade B areas should be sterile prior to use
5. 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
6. 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

Download GMP ANNEX 1 GUIDELINES
Whitepaper by Ansell below to learn more

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