By Mike Byrd, Director of Computer System Validation, ProPharma Group
Next week I’ll be in San Francisco conducting an ISPE training class on Risk Based Approach to GxP Process Control Systems. Attendees will include employees from a variety of regulated life cycle companies as well as FDA inspectors. The two-day course focuses on the application of GAMP® 5 guidance and principles to the validation of process control systems used in the manufacture of regulated drug and medical device products. This seems like a timely opportunity to re-visit the key GAMP® 5 concepts as they relate to establishing a compliant system validation methodology.
Concept 1: Product and Process Understanding
Understanding the product manufacturing or business process for which a computer system is being implemented is a critical first step to ensure the system meets its intended purpose. For product manufacturing processes, automation control systems are frequently required to maintain Critical Process Parameters (CPPs) in order to ensure product related Critical Quality Attributes (CQAs) are achieved. Systems that manage and maintain electronic data for regulated business processes must conform to critical record management requirements for the process. In both cases documented system requirements and specifications are the primary mechanisms for ensuring that product and process understanding is captured and reflected in the final system.