Best Practices In Commissioning And Qualification (C&Q)

Commissioning and qualification (C&Q) are crucial in pharmaceutical manufacturing to meet regulatory standards. The ISPE Baseline Guide highlights the importance of integrating C&Q activities for compliance and product safety. This article focuses on four stages of the C&Q lifecycle: requirement, design, verification, and quality decision.

An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety. The ISPE Baseline Guide: Commissioning and Qualification (Second Edition) merges the terms commissioning and qualification, emphasizing the necessity of unifying these activities within a science- and risk-based lifecycle approach.