A Collaborative Pathway To A Contamination Control Strategy

By Londa Ritchey, Quality Director, Cencora PharmaLex

Implementing an effective Contamination Control Strategy (CCS) is a cornerstone of the revised Annex 1 guidelines, which emphasize patient safety through meticulous contamination risk management. The CCS framework mandates that pharmaceutical manufacturers assess and mitigate contamination risks by thoroughly documenting control measures for microbial particulates, endotoxins, and non-viable particles.

This comprehensive strategy demands cross-functional collaboration, extending beyond the microbiology department to include facilities engineering and quality assurance teams. By fostering a cohesive, continuous improvement approach, companies can ensure robust contamination control and uphold drug safety standards.

This article explores the collaborative pathways necessary to develop, implement, and maintain a dynamic and effective CCS, especially in the face of challenges posed by older facilities.