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: 730233bbfa3d2be7fb27a1dd3608cf8378b132f0bf6d099da860d433372e219c
Primary Citations — 5 traced to source
- {"title":"ICH Q10 Pharmaceutical Quality System","url":"https://www.ich.org/page/quality-guidelines#5-1","section":"Q10 Section 4 (PQS elements), Section 5 (management responsibilities)"}
- {"title":"FDA Guidance on Process Validation - Q10 Implementation","url":"https://www.fda.gov/media/71021/download","section":"Integration of Q10 with GMP process validation"}
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