Health and Consumers Directorate General. “Outsourced Activities.” Chapter 7 of EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
- European Commission
This paper discusses the nuances of lifecycle validation implementation at contract manufacturing organizations (CMOs). Much has already been written on the general implementation of best practices for lifecycle validation, including the elements of Quality by Design (QbD). CMOs have unique considerations for lifecycle validation implementation, however. These include differentiating responsibility for various stages of lifecycle validation for both the CMO and the customer, implementing quality systems that allow flexibility for various customer approaches, process knowledge‐ transfer mechanisms between the CMO and the customer, and generating a quality agreement that captures the elements of lifecycle validation.