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ICH Q10 - Pharmaceutical Quality System
International (ICH)
v2008 (current)
6 domains
6 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.
Verified
Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (6)
ICH Q10 Product Lifecycle Stages
1 controls
| Code | Title |
|---|---|
| ICH-Q10-Lifecycle-PharmDev-TechTransfer-CommMfg-ProductDiscontinuation | ICH Q10 - 4 Product Lifecycle Stages - Pharmaceutical Development + Technology Transfer + Commercial Manufacturing + Product Discontinuation |
ICH Q10 Scope + ICH Family Coordination
1 controls
| Code | Title |
|---|---|
| ICH-Q10-Scope-PQS-ICH-Q8-Q9-Q11-Q12-ISO9001-GMP-Coord | ICH Q10 - Scope + Pharmaceutical Quality System (PQS) + ICH Q8/Q9/Q11/Q12 + ISO 9001 + GMP Coordination |
ICH Q10 Section 1 - PQS Enablers
1 controls
| Code | Title |
|---|---|
| ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9 | ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation) |
ICH Q10 Section 2 - Management Responsibility
1 controls
| Code | Title |
|---|---|
| ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-Review | ICH Q10 Section 2 - Management Responsibility + Leadership + Quality Policy + Planning + Resources + Communication + Management Review |
ICH Q10 Section 2 - Outsourced + Ownership
1 controls
| Code | Title |
|---|---|
| ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CRO | ICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management |
ICH Q10 Section 3 - Continual Improvement
1 controls
| Code | Title |
|---|---|
| ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReview | ICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review |
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
83%
5 controls mapped
Compare →ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
83%
5 controls mapped
Compare →NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
67%
4 controls mapped
Compare →+ 198 more: NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production (67%), ISO/IEC 23894:2023 (67%)
See all 201 mapped frameworks ↓Maps to 201 other frameworks
6 total controls
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
5 source controls mapped|4 target controls covered
83%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
5 source controls mapped|13 target controls covered
83%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
4 source controls mapped|5 target controls covered
67%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
4 source controls mapped|6 target controls covered
67%
ISO/IEC 23894:2023
4 source controls mapped|7 target controls covered
67%
Aged Care Quality Standards (Australia)
4 source controls mapped|4 target controls covered
67%
IEC 60601-1 - Medical Electrical Equipment Safety
4 source controls mapped|5 target controls covered
67%
NIST AI Risk Management Framework (AI RMF 1.0)
4 source controls mapped|4 target controls covered
67%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
4 source controls mapped|7 target controls covered
67%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
4 source controls mapped|9 target controls covered
67%
AS9100D - Aerospace Quality Management System
4 source controls mapped|10 target controls covered
67%
ISO/IEC 27003:2017
4 source controls mapped|10 target controls covered
67%
ISO 28001:2007 Supply Chain Security Management
4 source controls mapped|4 target controls covered
67%
NIST Cybersecurity Framework 2.0
4 source controls mapped|7 target controls covered
67%
ISO 20400:2017 - Sustainable Procurement
4 source controls mapped|7 target controls covered
67%
Annex 11 to EU GMP - Computerised Systems
4 source controls mapped|4 target controls covered
67%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
3 source controls mapped|2 target controls covered
50%
TEFCA - Trusted Exchange Framework and Common Agreement
3 source controls mapped|2 target controls covered
50%
Regulation on the European Health Data Space (EHDS)
3 source controls mapped|3 target controls covered
50%
Protective Security Policy Framework (PSPF) Release 2024
3 source controls mapped|1 target controls covered
50%
PSD2 SCA
3 source controls mapped|2 target controls covered
50%
OWASP Top 10:2025
3 source controls mapped|2 target controls covered
50%
OWASP DevSecOps Maturity Model (DSOMM)
3 source controls mapped|4 target controls covered
50%
OSFI B-13
3 source controls mapped|2 target controls covered
50%
Open Banking Security
3 source controls mapped|2 target controls covered
50%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
3 source controls mapped|3 target controls covered
50%
O-RAN WG11 Security Specification
3 source controls mapped|4 target controls covered
50%
NIST Privacy Framework
3 source controls mapped|3 target controls covered
50%
NIS2 Directive
3 source controls mapped|3 target controls covered
50%
NERC CIP
3 source controls mapped|2 target controls covered
50%
NAIC Insurance Data Security Model Law (MDL-668)
3 source controls mapped|1 target controls covered
50%
MTCS (Singapore)
3 source controls mapped|3 target controls covered
50%
Monetary Authority of Singapore Technology Risk Management Guidelines
3 source controls mapped|2 target controls covered
50%
MDS2 (Medical Device)
3 source controls mapped|3 target controls covered
50%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
3 source controls mapped|2 target controls covered
50%
IEEE 1686
3 source controls mapped|3 target controls covered
50%
ISO 22320:2018
3 source controls mapped|4 target controls covered
50%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
3 source controls mapped|2 target controls covered
50%
ISO 41001:2018 - Facility Management Systems
3 source controls mapped|8 target controls covered
50%
ISO 39001:2012 - Road Traffic Safety Management
3 source controls mapped|8 target controls covered
50%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
3 source controls mapped|8 target controls covered
50%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
3 source controls mapped|3 target controls covered
50%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
3 source controls mapped|4 target controls covered
50%
IAIS Insurance Core Principles (ICPs)
3 source controls mapped|3 target controls covered
50%
ISO/IEC 38500:2024 - Governance of IT
3 source controls mapped|4 target controls covered
50%
IEC 62304:2015 Medical Device Software Lifecycle Processes
3 source controls mapped|9 target controls covered
50%
FFIEC IT Examination Handbook
3 source controls mapped|4 target controls covered
50%
COSO Internal Control - Integrated Framework (2013)
3 source controls mapped|2 target controls covered
50%
PCI P2PE
3 source controls mapped|4 target controls covered
50%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
3 source controls mapped|7 target controls covered
50%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
3 source controls mapped|3 target controls covered
50%
ISO/IEC 27011:2024
3 source controls mapped|4 target controls covered
50%
ISO 37000:2021 - Governance of Organizations
3 source controls mapped|4 target controls covered
50%
BRCGS Global Standard for Food Safety Issue 9
3 source controls mapped|6 target controls covered
50%
21 CFR Part 211 - Current Good Manufacturing Practice
3 source controls mapped|2 target controls covered
50%
ISO/IEC 27006:2024
3 source controls mapped|4 target controls covered
50%
PCI SSF
3 source controls mapped|4 target controls covered
50%
PCI PIN Security
3 source controls mapped|4 target controls covered
50%
APRA CPS 234
3 source controls mapped|4 target controls covered
50%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|1 target controls covered
50%
Florida Digital Bill of Rights (FDBR)
3 source controls mapped|1 target controls covered
50%
French Sapin II Law (Law No. 2016-1691)
3 source controls mapped|2 target controls covered
50%
API 1164
3 source controls mapped|3 target controls covered
50%
ISO 27019
3 source controls mapped|4 target controls covered
50%
IEC 62443
3 source controls mapped|3 target controls covered
50%
NIST SP 1800-32
3 source controls mapped|3 target controls covered
50%
NIST SP 800-53 Rev 5
3 source controls mapped|4 target controls covered
50%
W3C Verifiable Credentials (VC) Data Model 2.0
2 source controls mapped|1 target controls covered
33%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
2 source controls mapped|1 target controls covered
33%
UK Bribery Act 2010
2 source controls mapped|1 target controls covered
33%
SWIFT CSCF
2 source controls mapped|2 target controls covered
33%
PTES
2 source controls mapped|1 target controls covered
33%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
2 source controls mapped|2 target controls covered
33%
Pakistan Personal Data Protection Bill 2023
2 source controls mapped|2 target controls covered
33%
OWASP MASVS
2 source controls mapped|1 target controls covered
33%
OWASP ASVS
2 source controls mapped|1 target controls covered
33%
OpenSSF Scorecard
2 source controls mapped|1 target controls covered
33%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
2 source controls mapped|2 target controls covered
33%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
2 source controls mapped|2 target controls covered
33%
Notifiable Data Breaches Scheme (Australia)
2 source controls mapped|1 target controls covered
33%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
2 source controls mapped|3 target controls covered
33%
NIST SP 800-92
2 source controls mapped|1 target controls covered
33%
NIST SP 800-88
2 source controls mapped|1 target controls covered
33%
NIST SP 800-63-4
2 source controls mapped|1 target controls covered
33%
NIST SP 800-61
2 source controls mapped|1 target controls covered
33%
NIST SP 800-39
2 source controls mapped|2 target controls covered
33%
NIST SP 800-37
2 source controls mapped|2 target controls covered
33%
NIST SP 800-30
2 source controls mapped|3 target controls covered
33%
NIST SP 800-146
2 source controls mapped|2 target controls covered
33%
NIST SP 800-145
2 source controls mapped|1 target controls covered
33%
NIST SP 800-144
2 source controls mapped|2 target controls covered
33%
NIST SP 800-137
2 source controls mapped|1 target controls covered
33%
NIST SP 800-123
2 source controls mapped|1 target controls covered
33%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
2 source controls mapped|1 target controls covered
33%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
2 source controls mapped|1 target controls covered
33%
Nigeria Data Protection Act 2023 (NDPA)
2 source controls mapped|3 target controls covered
33%
Nebraska Data Privacy Act
2 source controls mapped|3 target controls covered
33%
MITRE D3FEND
2 source controls mapped|1 target controls covered
33%
MITRE ATT&CK
2 source controls mapped|1 target controls covered
33%
ITU Radio Regulations and Space Security Standards
2 source controls mapped|1 target controls covered
33%
ITAR - International Traffic in Arms Regulations
2 source controls mapped|2 target controls covered
33%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
2 source controls mapped|1 target controls covered
33%
Israel Protection of Privacy Law (5741-1981)
2 source controls mapped|2 target controls covered
33%
ISMAP (Japan)
2 source controls mapped|2 target controls covered
33%
India Account Aggregator Framework (RBI)
2 source controls mapped|1 target controls covered
33%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
2 source controls mapped|2 target controls covered
33%
SANS Incident Handler's Handbook and PICERL Methodology
2 source controls mapped|2 target controls covered
33%
ISO 56002
2 source controls mapped|7 target controls covered
33%
ISO 37002:2021 - Whistleblowing Management Systems
2 source controls mapped|6 target controls covered
33%
ASIS SPC.1-2009 - Organizational Resilience Standard
2 source controls mapped|1 target controls covered
33%
ISO/IEC 27004:2016
2 source controls mapped|3 target controls covered
33%
ISO/IEC 30111:2019
2 source controls mapped|3 target controls covered
33%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
2 source controls mapped|3 target controls covered
33%
IEC 62351 - Power Systems Communication Security
2 source controls mapped|1 target controls covered
33%
ISO/IEC 29147:2018
2 source controls mapped|3 target controls covered
33%
Azerbaijan Law on Personal Data (2010)
2 source controls mapped|1 target controls covered
33%
AWS Well-Architected Security Pillar
2 source controls mapped|2 target controls covered
33%
21 CFR Part 58 - Good Laboratory Practice (GLP)
2 source controls mapped|2 target controls covered
33%
ISO/IEC 29134:2023
2 source controls mapped|3 target controls covered
33%
ISO/IEC 27014:2020
2 source controls mapped|4 target controls covered
33%
ISO 19011
2 source controls mapped|4 target controls covered
33%
ISO/IEC 27007:2020
2 source controls mapped|1 target controls covered
33%
FedRAMP High
2 source controls mapped|1 target controls covered
33%
NIST SP 800-53 Revision 5.1 HIGH
2 source controls mapped|1 target controls covered
33%
FedRAMP Moderate
2 source controls mapped|1 target controls covered
33%
NIST SP 800-53 Rev 5 MODERATE
2 source controls mapped|1 target controls covered
33%
NIST SP 800-53 Rev 5 LOW
2 source controls mapped|1 target controls covered
33%
ISO/IEC 27031:2011
2 source controls mapped|1 target controls covered
33%
ISO/IEC 27400:2022
2 source controls mapped|3 target controls covered
33%
COBIT 2019
2 source controls mapped|1 target controls covered
33%
Illinois Biometric Information Privacy Act (BIPA)
2 source controls mapped|3 target controls covered
33%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
2 source controls mapped|3 target controls covered
33%
ISO 27043
2 source controls mapped|1 target controls covered
33%
NIST SP 800-190
2 source controls mapped|2 target controls covered
33%
Azure Security Benchmark
2 source controls mapped|2 target controls covered
33%
ISO 8000 - Data Quality
2 source controls mapped|2 target controls covered
33%
ISO/SAE 21434
2 source controls mapped|1 target controls covered
33%
AICPA Privacy Management Framework (PMF)
2 source controls mapped|2 target controls covered
33%
Barbados Data Protection Act 2019
2 source controls mapped|1 target controls covered
33%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
2 source controls mapped|1 target controls covered
33%
ISO 26262:2018 - Functional Safety for Road Vehicles
2 source controls mapped|2 target controls covered
33%
ISO/IEC 27050 - Electronic Discovery (Parts 1-4)
2 source controls mapped|1 target controls covered
33%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
2 source controls mapped|2 target controls covered
33%
ISO 27017
2 source controls mapped|2 target controls covered
33%
ISO/IEC 29100:2024
2 source controls mapped|3 target controls covered
33%
ISO 31000:2018
2 source controls mapped|1 target controls covered
33%
ISO/IEC 25012:2008 - Data Quality Model
2 source controls mapped|2 target controls covered
33%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
2 source controls mapped|1 target controls covered
33%
ISO 27018
2 source controls mapped|2 target controls covered
33%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
2 source controls mapped|2 target controls covered
33%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
2 source controls mapped|2 target controls covered
33%
FTC GLBA Safeguards Rule (16 CFR Part 314)
2 source controls mapped|2 target controls covered
33%
EASA Part-IS - Information Security in Aviation
2 source controls mapped|4 target controls covered
33%
ISO 27005
2 source controls mapped|4 target controls covered
33%
ISO 31000
2 source controls mapped|4 target controls covered
33%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
2 source controls mapped|1 target controls covered
33%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
2 source controls mapped|2 target controls covered
33%
FBI CJIS Security Policy
2 source controls mapped|1 target controls covered
33%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
2 source controls mapped|4 target controls covered
33%
Authorised Economic Operator (AEO) Programmes - Global Standards
2 source controls mapped|4 target controls covered
33%
APRA CPS 230 Operational Risk Management
2 source controls mapped|5 target controls covered
33%
ISO 20000-1
1 source controls mapped|1 target controls covered
17%
Voluntary Principles on Security and Human Rights (VPs)
1 source controls mapped|1 target controls covered
17%
ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)
1 source controls mapped|1 target controls covered
17%
ISO 9001
1 source controls mapped|4 target controls covered
17%
ISO 30401
1 source controls mapped|2 target controls covered
17%
ISO 22000
1 source controls mapped|1 target controls covered
17%
ISO 55001
1 source controls mapped|2 target controls covered
17%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
1 source controls mapped|2 target controls covered
17%
ISO 45001
1 source controls mapped|1 target controls covered
17%
ISO 37301
1 source controls mapped|2 target controls covered
17%
ISO 37001
1 source controls mapped|2 target controls covered
17%
NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)
1 source controls mapped|1 target controls covered
17%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
17%
ITIL 4
1 source controls mapped|1 target controls covered
17%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|1 target controls covered
17%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
1 source controls mapped|1 target controls covered
17%
OWASP Top 10 for LLM Applications 2025
1 source controls mapped|1 target controls covered
17%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) - IASR Web Standard
1 source controls mapped|1 target controls covered
17%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
1 source controls mapped|1 target controls covered
17%
Modern Slavery Act 2018 (Australia)
1 source controls mapped|2 target controls covered
17%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
17%
ISO/IEC 27010:2015
1 source controls mapped|1 target controls covered
17%
ISO 22317
1 source controls mapped|1 target controls covered
17%
ISO 26000:2010
1 source controls mapped|1 target controls covered
17%
ISO 22318
1 source controls mapped|1 target controls covered
17%
BREEAM - Building Research Establishment Environmental Assessment Method
1 source controls mapped|1 target controls covered
17%
ISO 22316
1 source controls mapped|1 target controls covered
17%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
1 source controls mapped|1 target controls covered
17%
OECD Recommendation on Artificial Intelligence (2024 Update)
1 source controls mapped|1 target controls covered
17%
OECD AI Principles
1 source controls mapped|2 target controls covered
17%
NIS2 Directive Implementing Acts
1 source controls mapped|1 target controls covered
17%
New Zealand Information Security Manual (NZISM)
1 source controls mapped|1 target controls covered
17%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|1 target controls covered
17%
Japan AI Guidelines
1 source controls mapped|3 target controls covered
17%
IEEE 7000
1 source controls mapped|2 target controls covered
17%
ICMM Mining Principles (2024 Update)
1 source controls mapped|1 target controls covered
17%
AML/CTF Act 2006 (Australia)
1 source controls mapped|1 target controls covered
17%
FFIEC Cybersecurity Assessment Tool (CAT)
1 source controls mapped|2 target controls covered
17%
BS 65000:2014 - Guidance on Organizational Resilience
1 source controls mapped|2 target controls covered
17%
ICAO Annex 17 - Aviation Security (AVSEC)
1 source controls mapped|1 target controls covered
17%
Frequently Asked Questions
What is ICH Q10 - Pharmaceutical Quality System?
ICH Q10 - Pharmaceutical Quality System is a compliance framework from International (ICH) with 6 domains and 6 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 6 controls organised across 6 domains. The largest domains are ICH Q10 Product Lifecycle Stages (1 controls), ICH Q10 Scope + ICH Family Coordination (1 controls), ICH Q10 Section 1 - PQS Enablers (1 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 201 other compliance frameworks. The top mapping partners are PIC/S Guide to Good Manufacturing Practice for Medicinal Products (83% coverage), ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence (83% coverage), NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security (67% 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 6 controls and track your progress.
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