Answers to Common Annex 1 Questions
Annex 1
The EU GMP Annex 1 regulation defines the requirements for manufacturing sterile drug products destined for or imported into the EU. The 2022 revision—now fully in effect—replaces the 2008 version, aligning more closely with evolving global standards from WHO, PIC/S, and FDA.
Today, contamination control is more critical than ever. While core environmental monitoring requirements remain largely intact, the latest Annex 1 emphasizes strategic control through enhanced guidance on contamination control strategy (CCS), expanded sections on Cleanroom Classification and Monitoring, and a clear role for Quality Risk Management (QRM) in defining operations, processes, and limits. This shift underscores a more proactive and integrated approach to contamination control, elevating expectations for environmental monitoring and compliance.
Particle Measuring Systems (PMS) is here to help. Our on demand Annex 1 2022 Revision webinar offers a comprehensive, easy-to-reference guide, addressing common questions from both the session and our years of supporting customers in their compliance efforts.
Explore answers organized into key categories:
-
Limits, Alerts, and Alarms
-
Preparation and Qualification (CCS)
-
Continuous Monitoring
-
Specific Technologies
-
Specific Industries
-
Gear and Personnel
-
Recovery
-
Miscellaneous
Stay informed, stay compliant, and elevate your contamination control strategy with PMS.
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!
