EU GMP Annex 1 - 2022
Environmental Monitoring Changes
If you missed the popular EU GMP Annex 1 webinar, catch it now on-demand.
In our first educational webinar since the release of Annex 1 2022, PMS has put two of our experts to the task of explaining the environmental monitoring requirements, providing practical solutions, and answering your questions about the finalized EU GMP Annex 1 regulation.
Annex 1 Insights & Updates
The European Commission released its long-awaited Annex 1 regulation in August 2022. Our experts have reviewed this document carefully and have shared their insights with you.
Read our latest Annex 1 Application Note by clicking the title below:
Validation and Qualification Approach Outlined in New Annex 1 Revision
Below are some videos Particle Measuring Systems’ experts have created on single topics covered by Annex 1:
- Update: Continuous Viable Monitoring
- Alternative Micro Methods and Rapid Microbial
- Single-Use Considerations and a Solution
- Cleaning & Disinfection: What you need to know
- Classification – Qualification – Monitoring
- Quality Risk Management (QRM)
- Using a Risk Assessment to set microbiological plate incubation conditions
- Microbiological Plate Incubation
- Data Trending-Alert/Action Level Settings
Scroll down for more of our Annex 1 compliant viable nonviable instruments and data management solutions.
In this interview, Mark Hallworth, Sr. GMP Scientist, Particle Measuring Systems, discusses the new EU GMP Annex 1 release. Topics discussed include Annex 1’s history, timing, changes, and next steps.
