ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation

by ISPE

Covering a wide variety of manufacturing types, the ISPE Good Practice Practical Implementation of the Lifecycle Approach to Process Validation is a reference of technical and scientific detail to help organizations conduct process validation from scientifically sound development to robust reliable processes. It is intended to assist companies in understanding the application of global regulatory validation requirements by providing step by step implementation approaches to PV and leveraging process understanding to promote best practices. The use of statistical rationales within the different stages of the process validation lifecycle is explained. Case studies demonstrating the benefits of some of the Guide's practices in action are also included.

Paperback

Published January 1, 2019