Annex 1 Made Simple:
Answers to Your Most Asked Questions
Annex 1 sets EU standards for sterile drug manufacturing, revised in 2022 to align globally. Contamination control is now more strategic, with Annex 1 emphasizing CCS, expanded cleanroom guidance, and QRM to drive proactive, integrated monitoring and compliance.
This paper addresses key questions raised during our Annex 1 webinar, grouped into the following categories:
-
Limits, Alerts, and Alarms
-
Preparation and Qualification (CCS)
-
Continuous Monitoring
-
Specific Technologies
-
Specific Industries
-
Gear and Personnel
-
Recovery
-
Miscellaneous
Examples of questions covered:
- 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!
Stay informed, stay compliant, and elevate your contamination control strategy with PMS.
