Annex 1 and Impact on Primary Packaging

“As the saying goes you are only as strong as your weakest link and this goes for today’s Contamination Control Strategy (CCS). As drug manufacturers assess their CCS, the quality and control of materials from third party suppliers must be considered.

A critical success factor to a CCS is the ability of suppliers to create and maintain a holistic CCS. It must cover all aspects of the manufacturing operation, including:- environmental control, validation and monitoring, quality systems and processes,” said Sean Coombs, MedTech Technical Director, PM Group.

This discussion will explore lessons learned from:

• Establishment of the foundational Risk Management Plan
• Performance of a Maturity Assessment
• Mapping transformation with an eye toward short-term behaviour changes and long-term investments
• Development of an enterprise-wide Contamination Control Strategy
• Whether the FDA will leave the door open to component suppliers being audited

“We believe through partnering with our clients, vulnerabilities leading to potential contamination can be identified at their sites. It has been an informative journey and we believe what we identified as opportunities could be relevant at many other facilities,” said Alan Kelly, Aseptic Filling SME, PM Group.

Hear Sean, Alan and Niamh Bissett (Director, Operations PMO, West Pharma) at 11.10 on Wednesday 29th May 2024 at National Manufacturing Conference