Annex 1 is a regulation that outlines manufacturing requirements for sterile drugs made in and imported to the EU. In August 2022, a new revision of the EU GMP Annex 1 regulatory standard for sterile drug products was released, replacing the most recent draft from 2020 and the existing revision from 2008. Contamination control is vital in pharmaceutical manufacturing, and the requirements for environmental monitoring remain essentially the same in this revision; changes in the recent revision of Annex 1 highlight strategic control through further alignment with existing regulations from other organizations, the concept of a contamination control strategy (CCS), the separation and expanded guidance on Cleanroom Classification and Cleanroom Monitoring, and the definition of Quality Risk Management (QRM) as a central principle to defining processes, operations, and limits.
Particle Measuring Systems (PMS) recently hosted a webinar about the new Annex 1 2022 Revision (now available on demand).This easy-to-read compendium for quick consultation consists of questions received in conjunction with the webinar along with questions from years of supporting our customers in their compliance journey.
The questions are organized into the following categories:
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Limit, Alerts, and Alarms
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Preparation and Qualification (CCS)
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Continuous Monitoring
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Specific Technologies
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Specific Industries
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Gear and Personnel
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Recovery
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Miscellaneous
Some questions covered in this paper are:
- Why was the limit of 0.5 micron particles raised from 20 particles/m3 to 29 particles/m3 in this revision?
- How do you prepare to implement the Contamination Control Strategy (CCS)?
- Is it necessary to have a continuous monitoring system for particles in Grade A if we can justify in the CCS/QRM that a continuous one is not necessary?
- How does Annex 1 apply to Cell and Gene Therapy?
- Annex 1 refers to ISO 14644 which says the recovery test is not recommended for ISO 8 and 9? This would slightly contradict the Annex 1’s requirement. Could you explain?
- ….and more!
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