EU GMP Annex 1: What You Need to Know

courtesy of Particle Measuring Systems 

EU GMP Annex 1 is finally here.
Are you fully ready and do you have the most up to date information?

For years, we have all been preparing for EU GMP Annex 1, and there has been understandable confusion due to so many drafts. Particle Measuring Systems
has the EM Monitors, Resources, Advisory Services, and Data Management to support your compliance.

Webinar: Review of Annex 1 2022 Environmental Monitoring Changes

Two industry experts will explain the newest environmental monitoring  (EM) requirements, provide solutions, and answer your questions. This free webinar will include a live Q&A as well as the opportunity to submit your questions ahead of time.

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10 Short Videos to Answer Your Annex 1 Questions

Access a series of videos explaining environmental monitoring requirements. Watch them on our YouTube channel Some of popular Annex 1 videos include Continuous Viable MonitoringSingle Use Considerations and a SolutionQuality Risk Management (QRM)Meeting Auditor's Expectations by Understanding the Reasoning Behind the RulesData Trending-Alert/Action Level Settings, and many more.

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Advisory Services

We have experts ready to support you at every step in your contamination control process. Whether it is a non-compliance issue, a Risk Analysis (RA), or training employees, our team has the background, education, and industry expertise to support your success. 

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Microbial Monitors

Only PMS has the BioCapt® Single-Use impactor for continuous environmental monitoring. The single-use solution essentially eliminates false positives. Optionally, it can be used with the industry leading MiniCapt® Mobile Active Air Sampler for portable solutions or the MiniCapt® Remote for continuous monitoring. 

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Particle Counting

Explore complete solutions for continuous or mobile particle counting. For continuous monitoring, start with the new, award-winning IsoAir® Pro-E with a built-in pump, or choose an Airnet® that uses an exterior pump. The new Lasair® Pro is ideal for continuous or portable particle counting and meets all current regulatory requirements including Annex 1.

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Data Management

Get your definitive, modular, and turn-key solution for Cleanroom Contamination Monitoring, and monitor your viable and nonviable particles according to the most recent regulatory requirements. Count, report, document, and manage your environmental monitoring data meeting 21 CFR Part 11 data integrity requirements with our FacilityPro® facility monitoring systems.

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