Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations

Abstract

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.

Cite this paper

@inproceedings{Beall2015ImplementingLV, title={Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations}, author={Robert J. Beall and Kurtis Epp and C. Behring and Lois Hintz and Corden Pharma and Russell G. Miller and Lilly and Rusty Morrison and Mike Westerman and G. Allison and Joanne Barrick and Jennifer Walsh}, year={2015} }