EU GMP Annex 1

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Particle Loss in Transport Tubing: How to Address the New Annex 1 Requirement

 

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Your Guide to EU GMP Annex 1 - 2022 Environmental Monitoring Regulations

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.

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. If you missed the popular EU GMP Annex 1 webinar, watch it now on demand.

Read our latest Annex 1 Application Notes by clicking the title below:

Review of Annex 1: 2022
Annex 1 2022 vs. Annex 1 2008: A side-by-side comparison
Validation and Qualification Approach Outlined in Latest Annex 1 Revision

 

We have many more Annex 1 educational resources

Particle Measuring Systems process and regulatory Advisory Services are available in every major market no matter where you are located.
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2022 EU GMP Annex 1 Release

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.

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Contamination Control Products

Active Air Microbial Sampler: MiniCapt® Mobile

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Continuous Microbial Monitor:
BioCapt® Single-Use

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Microbial Remote Air Sampler: MiniCapt® Pro

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Portable Particle Counter: Lasair® Pro

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Remote Particle Counter: IsoAir® Pro

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

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FacilityPro® Cleanroom Software for Pharmaceuticals

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

Still have Annex 1 Questions?

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

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