ISPE Baseline Guide: Commissioning and Qualification: 5

This Guide focuses on engineering approaches and practices for timely, cost-effective delivery of manufacturing facilities, specifically addressing the process of designing, constructing, commissioning, and qualifying the facilities, utilities, and equipment regulated by the FDA or other health authorities. The Guide has incorporated comments from industry representatives, FDA field investigators, and personnel from FDA’s Center for Drug Evaluation and Research (CDER). The Guide is intended primarily for regulatory compliance in the US market, and it may be helpful to manufacturers for meeting European requirements.