Writing the CPV Plan & Report According to FDA/ICH Guidelines: Templates, Content & Review Strategy How to Write a CPV Plan & Report as per FDA and ICH Guidelines Stage 3 of pharmaceutical process validation—Continued Process Verification (CPV)—requires robust documentation to ensure lifecycle control of commercial manufacturing. The CPV Plan and CPV Report are the two foundational documents that define how the process will be monitored and how data trends are assessed. This article walks you through how to prepare, structure, and review CPV documentation in compliance with FDA, ICH, and EMA expectations. 1. What Is a CPV Plan? The…