On Demand

Review of Annex 1 2022: Environmental Monitoring Changes


EU GMP Annex 1 has been released after much anticipation, and new revisions tend to cause confusion. PMS has put two of our experts to the task of explaining the environmental monitoring requirements, providing practical solutions, and answering your questions.

Pharmaceutical manufacturing is performed in controlled environments to reduce contamination, and changes recently announced by Annex 1 focus more on strategic control than on the measurement of quality. This Quality by Design (QbD) ideal interconnects different disciplines to ensure that clean spaces are maintained according to their Classifications and that environmental monitoring procedures are based on risk to the product.

This free webinar will identify the aspects of Annex 1 that have, and have not, changed from previous versions, and how to meet the requirements. This webinar will cover:

  • Revised Annex 1 document layout for environments
  • Changes for cleanroom classification
  • Changes for cleanroom monitoring
Webinar Presented By:
Mark Hallworth
Global Pharma and Sr. GMP Advisor, Life Sciences Division

Mark Hallworth is the Life Sciences Global Manager and Senior GMP Advisor at Particle Measuring Systems. Over Mark’s long career in contamination control, he has managed the design, installation, and validation of over 200 environmental monitoring system projects worldwide. He has designed several products specific for pharmaceutical environmental monitoring, including particle counters for explosive and corrosive areas and 21 CFR part 11 compliant software for batch test and release. He currently lectures for the PDA, ISPE, and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has written over 100 technical papers on environmental monitoring and contributed to several books specific to this field. Most recently, Mark was a member of the international ISO 14644-21 technical committee responsible for reviewing and revising the standard. He was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.

David Crance
Life Sciences and OEM Sales Manager, Particle Measuring Systems

David Crance is the Life Sciences and OEM Sales Manager for Particle Measuring Systems and has worked in various roles in the Life Sciences business sector for over 35 years. He has lectured for pharmaceutical societies and organizations throughout the USA and APAC on environmental monitoring systems and their cGMP regulations. He is currently an instructor at the Parenteral Drug Association (PDA) headquarters in Bethesda, Maryland, USA, where he has been teaching contamination and aseptic control for the past 18 years. David has been involved in the design and implementation of over 700 environmental monitoring systems around the world. In his role as Life Sciences Sales Manager, David works with leading engineering firms and manufacturers in the design and effective implementation of environmental monitoring systems.