Articles tagged with “ema-annex-15”

Process Validation for Biotech: A PPQ & CPV Guide

Learn the lifecycle approach to biotech process validation. This guide covers PPQ and CPV planning, execution, and monitoring based on FDA, EMA, and ICH guidanc

40 min read

1/8/2026

process validation biotechnology ppq cpv quality by design (qbd)fda guidance ema annex 15 gmp manufacturing control strategy