ICH Q10 — Pharmaceutical Quality System
ICH Q10 describes a comprehensive model for an effective pharmaceutical quality system (PQS) based on ISO quality concepts, applicable GMP regulations, and ICH Q8 (Pharmaceutical Development) and Q9 (Quality Risk Management). It establishes a system for lifecycle management of pharmaceutical products covering development, technology transfer, commercial manufacturing, and product discontinuation. Adopted by FDA, EMA, and PMDA.
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Framework Domains (3)
Section 1 - Pharmaceutical Quality System
| Code | Title |
|---|---|
| Q10-1.1 | Scope |
| Q10-1.2 | ICH Q10 Objectives |
| Q10-1.3 | Enablers: Knowledge Management |
| Q10-1.4 | Enablers: Quality Risk Management |
Section 2 - Management Responsibility
| Code | Title |
|---|---|
| Q10-2.1 | Management Commitment |
| Q10-2.2 | Quality Policy |
| Q10-2.3 | Quality Planning |
| Q10-2.4 | Resource Management |
| Q10-2.5 | Internal Communication |
| Q10-2.6 | Management Review |
| Q10-2.7 | Management of Outsourced Activities and Purchased Materials |
Section 3 - Continual Improvement of Process Performance and Product Quality
| Code | Title |
|---|---|
| Q10-3.1 | Lifecycle Stage Goals |
| Q10-3.2 | Corrective Action and Preventive Action (CAPA) |
| Q10-3.3 | Change Management |
| Q10-3.4 | Management Review of Process Performance and Product Quality |
Maps to 525 other frameworks
Frequently Asked Questions
What is ICH Q10 — Pharmaceutical Quality System?
ICH Q10 — Pharmaceutical Quality System is a compliance framework from International (ICH) with 3 domains and 15 controls. ICH Q10 describes a comprehensive model for an effective pharmaceutical quality system (PQS) based on ISO quality concepts, applicable GMP regulations, and ICH Q8 (Pharmaceutical Development) and Q9 (Quality Risk Management). It establishes a system for lifecycle management of pharmaceutical products covering development, technology transfer, commercial manufacturing, and product discontinuation. Adopted by FDA, EMA, and PMDA. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does ICH Q10 — Pharmaceutical Quality System have?
ICH Q10 — Pharmaceutical Quality System has 15 controls organised across 3 domains. The largest domains are Section 2 - Management Responsibility (7 controls), Section 1 - Pharmaceutical Quality System (4 controls), Section 3 - Continual Improvement of Process Performance and Product Quality (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does ICH Q10 — Pharmaceutical Quality System map to?
ICH Q10 — Pharmaceutical Quality System maps to 525 other compliance frameworks. The top mapping partners are PIC/S Guide to Good Manufacturing Practice for Medicinal Products (53% coverage), ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence (53% coverage), BS 65000:2014 — Guidance on Organizational Resilience (53% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with ICH Q10 — Pharmaceutical Quality System compliance?
Start your ICH Q10 — Pharmaceutical Quality System compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ICH Q10 — Pharmaceutical Quality System requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 15 controls and track your progress.
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