Articles tagged with “good-manufacturing-practice”

FDA vs. EMA: Key Differences in US & EU Drug Regulation

An in-depth comparison of the FDA and EMA. Learn the key differences in US and EU drug approval processes, review timelines, GMP, and regulatory frameworks.

55 min read

11/18/2025

fda vs ema drug approval process pharmaceutical regulation regulatory affairs nda vs maa good manufacturing practice us drug regulation eu drug regulation

ALCOA+ Principles: A Guide to GxP Data Integrity

Learn the 9 ALCOA+ principles for GxP data integrity. This complete guide explains each attribute, FDA & EMA regulations, and compliance for pharma and life sci

50 min read

10/31/2025

alcoa+data integrity gxp fda guidance ema good manufacturing practice 21 cfr part 11 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