Implementing PIC/S Annex 1: Contamination Control Strategy With QRM Principles

Delve into the evolving requirements for Contamination Control Strategies (CCSs) within highly regulated industries, particularly focusing on the updated EU GMP and PIC/S Annex 1 guidelines. While CCS has long been a core concept, recent revisions emphasize the integration of Quality Risk Management (QRM) principles into the implementation of these strategies. This webinar provides a comprehensive overview of the key components and regulatory expectations of CCS, with an emphasis on contamination control’s role in safeguarding product quality, safety, and regulatory compliance in sectors like pharmaceuticals, biologics, and advanced therapies (e.g., cell and gene therapies).

The presentation addresses contamination control fundamentals, including risk mitigation, hazard identification, and how these elements align with QRM principles. The discussion also highlights the importance of Process Risk Management, focusing on comprehensive risk assessments across the entire production process, a critical aspect of the revised ICH Q9(R1). Understanding the connection between risk assessments and CCS is crucial for maintaining regulatory alignment and ensuring product integrity.

Gain the knowledge to effectively document, document, and implement contamination control measures in compliance with regulatory standards.