Implementation of Continued Process Verification Program for Post-Market Compliance and Product Success: Poster Presented at PDA Week 2025.

Abstract

Continued Process Verification (CPV) is the third stage of the FDA Process Validation guideline and is a critical component of modern pharmaceutical manufacturing, ensuring that processes remain in a state of control throughout the product lifecycle. However, CPV has historically been overlooked, with many companies unaware of the need for CPV program implementation as a regulatory requirement. This poster uses a case study to describe the key steps for successful CPV program implementation using a phased-approach for both legacy, approved products, as well as products entering process validation.