What ICH Q10 Pharmaceutical Quality System requires
This guideline provides a model for a pharmaceutical quality system (PQS) that applies throughout the product lifecycle, complementing regional GMPs by enhancing product quality and availability. It requires companies to establish and maintain a PQS with key elements including management responsibility, continual improvement processes, and management of outsourced activities, as outlined in Section 1.1.
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/Q10_Guideline.pdf
SHA-256 integrity: 0d5e5a2896e56a49f4ad7d7320b75d3622e5a459d8628d9581d24d35ab091b93
Primary Citations — 7 traced to source
- ICH Q10, Section 1.6: Enablers: Knowledge Management and Quality Risk Management
- ICH Q10, Section 2: Management Responsibility
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