A key part of Annex 1, due to come into effect on 25 August 2023, is the development of a holistic contamination control strategy (CCS). In this article, EPR’s Caroline Peachey summarises an expert panel discussion, which explored common challenges in implementing a CCS and made several recommendations.
As part of The Future of Pharma/Biopharma Analysis 2023, which took place on 28-29 June 2023, European Pharmaceutical Review (EPR) gathered an expert panel to discuss developing a modern contamination control strategy. The participants were: Dr Tim Sandle, Head of GxP Compliance at Bio Products Laboratory Limited (BPL) as moderator; Dr Edward Tidswell, Executive Director within the Microbiological Quality and Sterility Assurance organisation of Merck & Co; Frederic Ayers, Research Scientist at Eli Lilly and Company (now Senior Consultant – Microbiology at ValSource Inc); and Helen Gates, Strategic Technical Consultant Lead at Ecolab.
Opening the session, moderator Tim Sandle highlighted six fundamental aspects of contamination control. First is that the CCS extends to every aspect of sterile manufacturing operations (processes, equipment, facilities and manufacturing activities). Second, activities must be based on quality risk management principles, with a strong direction towards proactive assessments and then setting appropriate corrective and preventative action (CAPA). Next, a data-driven approach and scientific principles must be used, along with validated methods and processes. Fifth, the CCS should be seen as a holistic set of interactive and interlinked processes. Finally, development of the CCS cannot be viewed as a one-off process – it should be periodically reviewed and adaptive to changes made in processes.
Although core to the new EU GMP Annex 11 – mentioned more than 50 times in the 2022 version of the document – contamination control strategies are not new. Early adopters started putting these strategies together around 20 years ago. The panelists referred to other documents that are useful for CCS development: the 2014 Pharmaceutical Healthcare Sciences Society (PHSS) Technical Monograph No 20 Bio-Contamination2 as well as the Parenteral Drug Association (PDA) Technical Report 90: Contamination Control Strategy Development,3 published in February 2023.
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