Abstract

ABSTRACT Process validation is a requirement in heavily regulated industries such as the automotive and aerospace industries. Both the International Organization for Standardization (ISO) 9000/13485 and the U.S. Food and Drug Administration (FDA) Quality System Regulations (QSR) 820 Part 21 Code of Federal Regulations (CFR) "Quality Systems for Medical Devices," require process validation as a regulatory requirement. Design of experiment (DOE) statistical methods will allow these requirements to be met in the most resource-efficient manner possible, whilst providing a greater understanding of the process and highlighting opportunities for quality improvement. This paper provides an overview of the application of DOE techniques during key aspects of process validation and discusses two practical examples from medical device manufacturing. The attendant benefits of this type of procedural approach to the medical device sector are considered. From the results obtained, it is clear that meeting process validation requirements can be taken as an opportunity to better understand and improve manufacturing processes. As such, DOE techniques are pivotal in effectively achieving these aims in a manner that provides for regulatory compliance. INTRODUCTION Many medical device manufacturers view validation and other regulatory requirements as a life science sector burden. Whereas those companies which have developed a mature approach to regulatory compliance have an integrated approach, many others in this sector only consider this aspect once the main elements of product and process development have been completed. When viewed from this perspective, meeting regulations can become, for the most part, both a paper generating exercise and a drain on resources.