A risk-based process validation approach and establishment of a validation program for medical device manufacturers with an emphasis on equipment qualification

Abstract

The Food and Drug Administration's 2011 Process Validation Guidance for the medical device and pharmaceutical industry emphasizes utilizing a risk-based, decision-making procedure during process validation activities. Those guidelines, however, do not provide specific examples or a structured methodology to manufacturers for establishing a risk-based validation program. The focus of this project has been developed as part of a continuous quality improvement effort by the ABC medical device manufacturing company. This project evaluates current process validation requirements and guidelines for medical device manufacturers and outlines a step-by-step approach for a risk-based process validation program with an emphasis on equipment qualifications. Supporting documents such as validation plans, equipment qualification templates, and risk matrices are included. The goal is to help other medical device manufacturers implement a compliant process validation program