What ICH Q10 Pharmaceutical Quality System - Product Lifecycle Management requires
ICH Q10 describes a comprehensive pharmaceutical quality system (PQS) model covering the entire product lifecycle from development through discontinuation. It builds on Good Manufacturing Practice (GMP) requirements and supplements ICH Q8 and Q9, establishing four PQS elements: management responsibilities, process performance and product quality monitoring, change management, and continual improvement. The framework enables pharmaceutical companies to implement science-based quality systems that assure product quality, safety, and efficacy.
Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://database.ich.org/sites/default/files/Q10_Guideline.pdf
SHA-256 integrity: a392d610c4e6d90fac2794badf42782c08e872c91360527a943f038c93c80f78
Primary Citations — 5 traced to source
- Q10 Section 4 (PQS elements), Section 5 (management responsibilities) — ICH Q10 Pharmaceutical Quality System
- Integration of Q10 with GMP process validation — FDA Guidance on Process Validation - Q10 Implementation
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