Lifecycle Approach to Process Validation and Its Implementation in Pharmaceutical Industry

Abstract

Process Validation is a GMP concept and is required by the agencies to assure quality of the manufactured drug products. The need, motivation, understanding and the practices of Process validation have evolved enormously from the time of its inception. The lifecycle (modern) approach of process validation and its elements are discussed in detail here. The review article aims to provide a general understanding of the concepts of lifecycle approach of process validation. The review further provides an illustration for practical implementation of the concepts outlined for the pharmaceutical manufacturing industry through an example of a hypothetical sterile injectable product. A properly developed process/product according to principles of lifecycle approach discussed in this article should meet the expectations of majority of regulatory agencies.