EU GMP Annex 1

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:
  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.

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. 

Contamination Control Products

Active Air Sampler: MiniCapt® Mobile

Learn More
Microbial Monitor: BioCapt® Single-Use

Learn More
Remote Microbial Air Sampler: MiniCapt® Pro

Learn More
Airborne Particle Counter: Lasair® Pro

Learn More
Remote Particle Counter: IsoAir® Pro

Learn More
Airnet® II / IIs Remote Air Particle Counter (2 Channels)

Learn More
FacilityPro® Cleanroom Software for Pharmaceuticals

Learn More

Or, let us help you find a solution for your contamination monitoring:

Still have Questions?

Our EU GMP Annex 1 experts are ready to answer your questions or get a quote ready for you.

Contact an Expert Request a Quote