New EU GMP Annex1
Posted by Ian Norman on
The new EU GMP Annex 1 is a revised guideline for the manufacture of sterile medicinal products. It was published on August 25, 2022, and came into force on August 25, 2023. The new Annex 1 introduced several important changes to environmental monitoring in sterile manufacturing facilities. Some of these are:
- Risk-Based Approach: The new guidelines emphasize a risk-based approach to designing environmental monitoring plans. This means understanding the cleanroom areas and identifying potential contamination sources and focuses monitoring on the most critical areas.
- Monitoring Requirements: There are more detailed requirements for both viable (microbial) and non-viable (particulate) monitoring. This includes continuous monitoring to detect any contamination events promptly.
- Sampling Methods: The new Annex 1 requires the evaluation of sampling methods to ensure they do not introduce contamination.
- Data Evaluation: There is more focus on the evaluation of environmental monitoring data, including the use of statistical methods to identify trends and deviations.
If your environmental monitoring does not comply with EU GMP Annex1 please contact us to find out how PMT (GB) can assist with your particle and microbial monitoring with our range of particle counters, monitoring software and microbial air samplers.