UNITED STATES info@pmeasuring.com +1 303 443 7100
UNITED KINGDOM info.uk@pmeasuring.com +44 01733 454 207
IRELAND info.ie@pmeasuring.com +353 1 295 7373

Essential Insights into EU GMP Annex 1: 2022
Environmental Monitoring Updates

Unlocking EU GMP Annex 1: 2022 Environmental Monitoring Simplified

A Shift in Regulatory Expectations

The EU GMP Annex 1 revision, released in August 2022, introduced sweeping changes to the regulatory framework for sterile drug manufacturing. With the operational deadline of August 25, 2023, now fully in effect, pharmaceutical manufacturers are navigating a transformed landscape. This revision nearly quadruples the length of the previous 2008 version, introducing a more strategic focus on contamination control. No longer just about measurement, the updated Annex 1 embeds Quality Risk Management (QRM) and a comprehensive Contamination Control Strategy (CCS) into every stage of aseptic manufacturing.

Learn more by reading Review of Annex 1: 2022

Aligning with Global Standards

The updated Annex 1 aligns closely with World Health Organization (WHO), Pharmaceutical Inspection Cooperation Scheme (PIC/S), and FDA guidelines, reflecting a global shift toward a holistic contamination control approach. It divides the guidance into 10 clear sections, including separate and expanded coverage of Certification and Monitoring, distinguishing facility qualification from routine monitoring. Enhanced descriptions of Environmental Monitoring integrate QRM principles, emphasizing proactive risk management rather than reactive compliance.

Get this Annex 1 2022 vs. Annex 1 2008: A side-by-side comparison

Continuous Improvement in 2025 and Beyond

As we move through 2025, the expectations for pharmaceutical manufacturers go beyond baseline compliance. The latest Annex 1 serves as a roadmap for embedding continuous improvement and innovation into contamination control strategies. Companies that embrace this holistic approach will not only meet regulatory requirements but also strengthen their operational resilience and product integrity in a rapidly evolving global market.

Learn more by reading Validation and Qualification Approach Outlined in Latest Annex 1 Revision

Review of Annex 1 2022 (Webinar)

Mark Hallworth, Sr. GMP Scientist at Particle Measuring Systems, outlined key updates on Annex 1 compliance, focusing on 2025 changes to environmental monitoring. The revision distinguishes certification from monitoring and emphasizes contamination control and QRM.

While core principles remain, enhanced guidance clarifies workflows, stresses critical area checks, and highlights rapid responses to contamination.

In 2025, Annex 1 guidance supports proactive quality protection and continuous improvement.

Tell us how we can help you with compliance. 

Still have Annex 1 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

Contamination Control Products

Active Microbial Air Sampler: MiniCapt® Mobile

Learn More
Microbial Impactor: BioCapt® Single-Use

Learn More
Remote Microbial Air Sampler: MiniCapt® Pro

Learn More
Clean Room Particle Counter: Lasair® Pro

Learn More
Remote Particle Counter: IsoAir® Pro

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

Learn More
Cleanroom Environmental Monitoring Software FacilityPro®

Learn More

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

PMS Logo particle Measuring systems
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.