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, updated for 2026. Learn the key differences in US and EU drug approval processes, review timelines, GMP, FDORA reforms, EU pharma legislation overhaul, and regulatory frameworks.

60 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. Updated for 2026 with ICH E6(R3) finalization, EU GMP Chapter 4 ALCOA++ draft, and latest FDA enforcement trends

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