Overcoming Hurdles With A Contamination Control Strategy

By Noelle Clifford

The latest revision of the EU GMP Annex 1, effective from 2023, underscores the necessity for a proactive approach to contamination control through a formalized Contamination Control Strategy (CCS). This directive is integral to Quality Risk Management (QRM), compelling manufacturers to identify, evaluate, and manage potential quality risks across the entire manufacturing process.

Developing and implementing an effective CCS poses several challenges for manufacturers, as it requires a comprehensive understanding of where contamination risks may arise and how current controls can be optimized. The CCS is not merely a regulatory requirement but a strategic approach to mitigating microbial, viral, particulate, cross-product, or chemical contamination risks.

In this article, we delve into the importance of a facility-specific CCS, explore common hurdles encountered in its development, and provide practical advice on creating a robust and compliant strategy. By addressing these elements, manufacturers can not only meet regulatory expectations but also enhance their overall contamination control measures, ensuring the production of safe and high-quality pharmaceutical products.