Control Strategy Articles

Process Validation for Biotech: A PPQ & CPV Guide

Lifecycle approach to biotech process validation: PPQ and CPV planning, execution, and monitoring under FDA, EMA Annex 1/15, ICH Q9(R1), Q12, and Q13 guidance.

45 min read

1/8/2026

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

ICH Q8 Explained: A Guide to Pharmaceutical Development & QbD

Learn about the ICH Q8 guideline for pharmaceutical development. This in-depth guide explains Quality by Design (QbD), QTPP, CQAs, design space, and includes 2025-2026 updates on ICH Q13, Q14, and AI in manufacturing.

45 min read

11/15/2025

ich q8 quality by design qbd pharmaceutical development design space qtpp critical quality attributes ich guidelines control strategy ctd module 3.2.p.2

Articles tagged with “control-strategy”