What ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients requires
This guide provides Good Manufacturing Practice (GMP) principles for manufacturing Active Pharmaceutical Ingredients (APIs), requiring a comprehensive quality management system to ensure APIs meet purity and quality standards. It applies to all manufacturers of APIs for human drug products, with the core requirement being the establishment of an independent Quality Unit as mandated by Section 2.2.
Pillar: Medical & Healthcare · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://database.ich.org/sites/default/files/Q7_Guideline.pdf
SHA-256 integrity: 7395d85f78c2384d450db7dbbe4c602e6d4bd201cb11a17130765aefc035baba
Primary Citations — 8 traced to source
- ICH Q7, Section 2: Quality Management
- ICH Q7, Section 3: Personnel
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