What ICH Q9(R1) Quality Risk Management requires
ICH Q9(R1) requires pharmaceutical manufacturers to implement a quality risk management system, as outlined in Section 1.1, to ensure the quality of their products. This applies to all pharmaceutical companies, as stated in Article 1 of the ICH Q9(R1) guideline.
Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use · Version: 1.0.0 · Last updated:
Primary source: https://www.ich.org/page/quality-guidelines
SHA-256 integrity: c22c134ef1459a1edafc5fd72ae21ce8614c0cb0aa8bd8bdf1877d43a108d5ee
Primary Citations — 5 traced to source
- ICH Q9(R1), Section 1.1 - Introduction
- ICH Q9(R1), Section 2.1 - Quality Policy
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