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ICH Q10 Pharmaceutical Quality System - Design, Development, Manufacturing and Discontinuation: Quality System Elements and Enablers

This regulation requires pharmaceutical manufacturers to establish a quality system that includes design, development…

What ICH Q10 Pharmaceutical Quality System - Design, Development, Manufacturing and Discontinuation: Quality System Elements and Enablers requires

This regulation requires pharmaceutical manufacturers to establish a quality system that includes design, development…

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Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use · Version: 1.0.1 · Last updated:

Primary source: https://www.ich.org/page/quality-guidelines

SHA-256 integrity: bbbb5ecb4e87c81b905f22a2c82719e2296f2223ee011b70dba2473843075829

Primary Citations — 9 traced to source

  • ICH Q10, Clause 1.1 - Pharmaceutical Quality System
  • ICH Q10, Clause 1.2 - Quality Policy

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