EU GMP Annex 1

EU GMP Annex 1 – 2022

Environmental Monitoring Changes

If you missed the popular EU GMP Annex 1 webinar, watch 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:

1. Update: Continuous Viable Monitoring
2. Alternative Micro Methods and Rapid Microbial
3. Single-Use Considerations and a Solution
4. Cleaning & Disinfection: What you need to know
5. Classification – Qualification – Monitoring
6. Quality Risk Management (QRM)
7. Using a Risk Assessment to set microbiological plate incubation conditions
8. Microbiological Plate Incubation
9. Data Trending-Alert/Action Level Settings 

Scroll down for more of our Annex 1 compliant viable nonviable instruments and data management solutions.

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