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