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 (8)
Continual Improvement
| Code | Title |
|---|---|
| Q10-3.1 | Process Performance and Product Quality Monitoring |
| Q10-3.2 | CAPA System |
| Q10-3.3 | Change Management System |
| Q10-3.4 | Management Review of Process Performance |
| Q10-Audit | Internal Audit Programme |
Lifecycle Stages
| Code | Title |
|---|---|
| Q10-Stage1 | Pharmaceutical Development |
| Q10-Stage2 | Technology Transfer |
| Q10-Stage3 | Commercial Manufacturing |
| Q10-Stage4 | Product Discontinuation |
Management Responsibility
| Code | Title |
|---|---|
| Q10-2.1 | Management Responsibility and Leadership |
| 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 | Outsourced Activities and Materials |
| Q10-2.8 | Change Management of Ownership |
PQS Enablers
| Code | Title |
|---|---|
| Q10-4.1 | Knowledge Management |
| Q10-4.2 | Quality Risk Management |
PQS Foundation
| Code | Title |
|---|---|
| Q10-1.1 | Pharmaceutical Quality System Scope |
| Q10-1.5 | Alignment with ISO 9001 and GMP |
Section 1 - Pharmaceutical Quality System
| Code | Title |
|---|---|
| Q10-1.1 | Pharmaceutical Quality System 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 Responsibility and Leadership |
| 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 | Outsourced Activities and Materials |
Section 3 - Continual Improvement of Process Performance and Product Quality
| Code | Title |
|---|---|
| Q10-3.1 | Process Performance and Product Quality Monitoring |
| Q10-3.2 | CAPA System |
| Q10-3.3 | Change Management System |
| Q10-3.4 | Management Review of Process Performance |
Your Compliance Coverage
If you comply with ICH Q10 — Pharmaceutical Quality System, you already cover:
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
33%
8 controls mapped
Compare →ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
33%
8 controls mapped
Compare →BS 65000:2014 — Guidance on Organizational Resilience
33%
8 controls mapped
Compare →+ 546 more: TISAX — Trusted Information Security Assessment Exchange (29%), ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories (29%)
See all 549 mapped frameworks ↓Maps to 549 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 8 domains and 36 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 36 controls organised across 8 domains. The largest domains are Management Responsibility (8 controls), Section 2 - Management Responsibility (7 controls), Continual Improvement (5 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 549 other compliance frameworks. The top mapping partners are PIC/S Guide to Good Manufacturing Practice for Medicinal Products (33% coverage), ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence (33% coverage), BS 65000:2014 — Guidance on Organizational Resilience (33% 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 36 controls and track your progress.
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