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
Meet the speakers:
Mark Hallworth is the Pharmaceutical Manager for Particle Measuring Systems. He was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control.” He is part of ISO 14644 working group 15, and currently lectures for the PDA, ISPE, and other international societies.
David Crance is the Life Sciences and OEM Sales Manager for PMS. With over 35 years of experience in contamination control and systems, he has been involved in the design and implementation of more than 700 environmental monitoring systems. He has been an instructor at the Parental Drug Association (PDA) for 18 years in Bethesda, Maryland.