Description
Presented by: Cody Beaumont, Associate Director, Quality Compliance and Regulatory, CAI
Annex 1 and a Contamination Control Strategy are critical aspects of pharmaceutical manufacturing, focusing on maintaining quality, safety, and compliance as is expected in a regulatory setting. Annex 1 of the European Union’s Good Manufacturing Practice (GMP) serves as a guideline and cornerstone for sterile medicinal production manufacturing, providing detailed requirements for cleanroom design, environmental monitoring, and personnel practices.
Points:
- Relationship of Annex 1 and the need for a CCS
- Risk Management Approach to CCS
- What’s new in CCS
- How to develop a meaningful and process specific CCS
Takeaway:
- Tools to support CCS development.
- Templates and upcoming white paper on contamination control strategy and contamination control program maintenance