Articles tagged with “pharmaceutical-quality-system”

FDA First AI cGMP Warning Letter: Manufacturing Lessons

Examine the FDA's first warning letter for AI misuse in cGMP manufacturing. This review details compliance lessons and human oversight requirements for QA.

40 min read

4/23/2026

fda warning letter ai in manufacturing cgmp compliance pharmaceutical quality system process validation quality assurance regulatory compliance

ICH Q10 Guide: Implementing a Pharmaceutical Quality System

An in-depth guide to ICH Q10 Pharmaceutical Quality Systems (PQS), updated for 2026 with ICH Q9(R1), Q12-Q14 developments, FDA QMM program updates, and AI-driven quality management trends.

30 min read

10/13/2025

ich q10 pharmaceutical quality system pqs good manufacturing practice gmp quality risk management capa system continual improvement product lifecycle regulatory compliance