Building an Effective Contamination Control Strategy for Sterile Filtration

The newly revised Annex 1 emphasizes Quality Risk Management (QRM) and highlights how this can inform and direct a contamination control strategy (CCS). The CCS is not a new initiative. The intention of Annex 1 is to use this as a single point of reference that helps define critical control points through data-informed risk assessment, and ultimately to demonstrate a state of process control. But this is not a static state, and the CCS is expected to be a living document, with periodic reviews that drive continuous improvement to further reduce the risk of contamination.  Sterile filtration plays a critical role in aseptic manufacturing. As innovation in new therapeutic modalities evolve, it is important that end-users understand how to implement a CCS throughout the product lifecycle. Here we outline regulatory expectations for sterile filtration at each stage of product development, and how those feed into the CCS. We also show how shared responsibilities between the end-user and supplier help ensure compliance to Annex 1. Finally, we provide a perspective from a Contract Development and Manufacturing Organization (CDMO) on best practices to ensure compliance with Annex 1.