Frameworks / ICH Q10 - Pharmaceutical Quality System / ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-Review ICH Q10 - Pharmaceutical Quality System
ICH Q10 Section 2 - Management Responsibility
ICH Q10 - Pharmaceutical Quality System ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-Review: ICH Q10 Section 2 - Management Responsibility + Leadership + Quality Policy + Planning + Resources + Communication + Management Review Section 2 establishes management responsibility for the Pharmaceutical Quality System (PQS). Section 2.1 Management Commitment and Leadership: senior management has ultimate responsibility for establishing + maintaining + continual improvement of PQS; demonstrate commitment through visible engagement + resource allocation + decision-making + accountability + setting tone at the top + culture of quality + product safety; ensure PQS effectiveness; designate Quality Unit / Quality Function (independent from operations + production); periodic review at appropriate intervals. Section 2.2 Quality Policy: documented + communicated + understood across organisation + linked to corporate strategy + reviewed periodically + commits to compliance + continual improvement + customer/patient focus. Section 2.3 Quality Planning: identifying + planning + communicating + measuring objectives + targets + KPIs; cascading from corporate to functional to site to process level; align with regulatory requirements + business strategy + ICH Q8/Q9/Q11/Q12. Section 2.4 Resource Management: ensure adequate human + facility + utilities + equipment + materials + IT systems + qualifications + training + experience; competence assessment + development planning + succession. Section 2.5 Internal Communication: between management levels + functions + sites; communicate PQS objectives + status + issues + lessons learned + good practices; Quality Unit + Operations interface. Section 2.6 Management Review of PQS: periodic review of: PQS effectiveness + objective achievement + audit results + customer/regulatory feedback + supplier performance + CAPA status + improvement initiatives; output: improvement actions + resource allocation + PQS evolution; documented + actioned + monitored. Coordinates with FDA Quality Metrics + EMA + PMDA + ISO 9001 Section 5 (Leadership) + Section 6 (Planning) + Section 9 (Performance Evaluation). ICH Q10 Section 2 + Management Responsibility applies.
Maintained by Gerard Blokdyk · Verified against the published standard 31 May 2026 · Control text last updated 21 May 2026 What else in your programme already covers this This control maps to 220 controls across 130 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
ISO-15189-5.1 Legal entity ISO-15189-5.4 Structure and authority ISO-15189-5.6 Risk management ISO-15189-6.7 Service agreements ISO-15189-7.4 Post-examination processes ISO-15189-8.4 Control of records PICSGMP-1 Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management PICSGMP-2 Chapter 2: Personnel - Qualified Personnel, Key Responsibilities, Training PICSGMP-5 Chapter 5: Production Operations and Material Management PICSGMP-7 Chapter 7: Outsourced Activities and Supplier Management ACQS-3-1 Safe and Effective Care ACQS-8-2 Clinical Governance ACQS-8-4 Risk Management FDBR-702 Definitions (§501.702) FDBR-704 Exemptions (§501.704) FDBR-Scope-Defs Scope, Applicability Thresholds and Definitions (Fla. Stat. 501.701, 501.702, 501.703, 501.704) 60601-1.12 Accuracy of controls and instruments 60601-1.3 Terminology and definitions 60601-1.4.1 General requirements IEC62304-5.2 Software Requirements Analysis IEC62304-5.3 Software Architectural Design IEC62304-7.2 Risk Control Measures ISO-19650-1-4 Information management concepts ISO-19650-1-7 Common Data Environment (CDE) concept ISO-19650-3-5.3 Trigger events for information exchange ISO-22320-5.1 General process requirements ISO-22320-5.3 Incident management structure (command) ISO-22320-5.4 Roles and responsibilities ISO23894-1 Scope of AI Risk Management ISO23894-3 AI-Specific Terminology ISO23894-6.2 Scope, Context and Criteria 27004-3 Terms and definitions 27004-A.2 Patching and Vulnerability Measures 27004-B.1 Example measurement definitions 27557-1 Scope 27557-3 Terms and definitions 27557-6.2 Scope, context, and criteria for privacy 29100-1 Scope 29100-3 Terms and definitions 29100-4.1 Actors and roles MDS2-Audit-Logging-AUDT-Integrity-IGAU-Cybersecurity-Risk-CYBR-Monitoring MDS2 Audit Controls + AUDT + Integrity + IGAU + Cybersecurity Risk + CYBR + Continuous Monitoring MDS2-PHI-Data-Handling-DATA-Storage-STCF-Transmission-TXCF-TXIG-Encryption-FIPS MDS2 PHI Handling + DATA + STCF Storage + TXCF Transmission + TXIG Integrity + Encryption + FIPS MDS2-Person-Node-Authentication-Authorization-Auto-Logoff-AUTH-PAUT-NAUT MDS2 Authentication + Authorization + Auto Logoff + PAUT + NAUT + AUTH + Identity Management NDPA-1 Applicability, Scope, and Carve-Outs NDPA-2 Consumer Rights - Access, Correct, Delete, Portability, Appeal NDPA-5 Privacy Notice, Data Minimisation, and Purpose Limitation NG-NDPA-1 Scope, Applicability, and Establishment of Nigeria Data Protection Commission NG-NDPA-2 Lawful Basis, Consent, and Data Protection Principles NG-NDPA-5 Security of Processing, Breach Notification, and DPIA ORANWG11-2 O-RAN Interface Security: E2, A1, O1, O2, Open Fronthaul ORANWG11-3 Cryptography, TLS, SSH, IPsec, and PKI Lifecycle Management ORANWG11-6 Security Test Specifications, Certification, and Conformance EHDSREG-1 Mandatory Requirements for EHR Systems (Articles 14-29) EHDSREG-3 Secondary Use - Health Data for Research and Innovation EHDSREG-5 Cross-Border Health Data Flows 58.1 Scope 58.3 Definitions AL-DPA-1 Scope and Definitions AL-DPA-3 Lawful Basis for Processing AT-DSG-2 Section 2 - Scope and application AT-DSG-8 Section 22 - Functions and powers of the DPA MLE.1 Machine Learning Requirements Analysis MLE.3 Machine Learning Training CA-10 Selects and Develops Control Activities CA-12 Deploys Through Policies and Procedures DA-1 Enterprise Data Architecture DIQ-2 Data Quality Management FEDRAMP-CM-6 Configuration Settings FEDRAMP-CP-9 System Backup ISO-20400-4.2 Principles of sustainable procurement ISO-20400-7.2 Integrating sustainability into specifications ISO-41001-4.1 Understanding the organization and its context ISO-41001-4.3 Determining the scope of the FM management system ISO-56002-4.3 Determining the scope of the innovation management system ISO-56002-8.3.4 Develop solutions ISO8000-DQM-02 Data Quality Dimensions ISO8000-MDG-03 Continuous Improvement ISO-17025-5.1 Legal entity ISO-17025-5.4 Personnel for the management system ISO-25012-5.2 Defining data quality measures ISO-25012-5.3 Planning and performing data quality evaluations 27011-1 Scope 27011-3 Terms and definitions 27014-1 Scope 27014-3 Terms and definitions 29147-3 Terms and definitions 29147-9.2 Contact mechanisms and scope 30111-3 Terms and definitions 30111-5.1 Organizational policy IsraelPPL-Database-Registration-Definition-Document-Security-Level-Classification-Sec7-8-PPA-Registry Israel POPL Database Registration + Section 7 Database Definitions + Section 8 Registration Requirement + Database Definition Document + Security Level Classification + PPA Public Registry + Amendment 13 Threshold Changes IsraelPPL-Scope-5741-1981-Knesset-Amendment13-March2024-BasicLaw-Dignity-Sec1-Right-Privacy Israel Protection of Privacy Law 5741-1981 Scope + Knesset + Amendment No. 13 March 2024 + Basic Law Human Dignity and Liberty + Section 1 Right to Privacy + Constitutional Status + Chapter 1 Infringement of Privacy MTCS-Governance-ISMS-Risk-HR-Lifecycle-Compliance-Cloud-Strategy-Roles-Responsibilities MTCS Governance + ISMS + Risk Management + HR Security + Cloud Service Lifecycle + Compliance + Roles MTCS-Logging-Monitoring-Compliance-Audit-SLA-Configuration-SIEM-SOAR-Cloud-Monitoring-CSPM MTCS Logging + Monitoring + Compliance + Audit + SLA + Configuration + SIEM + SOAR + CSPM NIST-CSF-DE.AE-08 Incidents are declared when adverse events meet the defined incident criteria NIST-CSF-PR.AA-05 Access permissions, entitlements, and authorizations are defined in a policy, managed, enforced, and reviewed, and incorporate the principles of least privilege and separation of duties NISTSP82-1 OT Security Program Governance, Policy, Roles, and Safety-Security Integration NISTSP82-7 OT Incident Response, Forensics, Recovery, and Continuity NISTSP34-1 Contingency Planning Policy, Programme, and Plan Coordination NISTSP34-2 Business Impact Analysis (BIA): Critical Resources, Recovery Priorities NRC7354-2 Critical Digital Asset (CDA) Identification, Scope, and Boundary NRC7354-4 Security Controls Implementation per NRC RG 5.71 Appendix B/C DSOMM-1 Culture, Organization, Education, and Governance DSOMM-2 Implementation Practices, Secure Coding, and Threat Modelling ASTWO-7 Deficiency Evaluation, Material Weakness, and Communication ASTWO-8 ICFR Opinion, Basis, Definition, Limitations, Combined vs Separate Reports PAKPDPB-7 NCPDP, Registration, Records, Processor Contracts, DPO PAKPDPB-8 Enforcement, Penalties, Complaints, Retention, Training PICERL-P2 Risk Assessment PICERL-P3 CSIRT Formation C1 Organizational Boundary C3 Scope 1 and 2 Coverage TEFCAREC-1 Common Agreement Conformance and Onboarding TEFCAREC-2 Privacy, Security, Minimum Necessary CFR211-A-3 Section 211.3 - Definitions 4.4.1 Resources, Roles, Responsibility, and Authority AWWA-1.1 Security Policy and Governance AZ-DPA-2 Article 2 - Basic Concepts CPG-6.B Supply Chain Incident Reporting COBIT-BAI02 Managed requirements definition QMSR-820.10 Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10) FFIEC-05 Roles and responsibilities definition FTC-Safeguards-Scope-Defs Scope, Definitions and Financial Institution Applicability (16 CFR 314.1, 314.2) CA-9 Internal System Connections CA-9 Internal System Connections Sapin2-Pillar1-Code-of-Conduct Pillar 1 - Anti-Corruption Code of Conduct ICP-1 Objectives, Powers and Responsibilities of the Supervisor 62351-2 Glossary of terms IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilities IMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA ISO-14064-1-5.1 Organizational boundaries ISO-26262-3-5 Item definition ISO28001-PI-01 Personnel Security Screening ISO27003-4.3 Determining the scope of the information security management system 27007-5.2 Audit Programme Objectives ISO27043-04 Roles and responsibilities definition 27050-1.4 Terms and definitions 27400-3 Terms and definitions 29115-3 Terms and definitions 29134-3 Terms and definitions ISO21434-04 Roles and responsibilities definition ITAR-Scope-AECA-22USC2778-22CFR120-130-DDTC-USML-21Categories-DefenseArticle-Service-TechnicalData ITAR Scope + Arms Export Control Act (22 USC 2778) + 22 CFR Parts 120-130 + Directorate of Defense Trade Controls (DDTC) + United States Munitions List (USML) 21 Categories + Defense Article/Service/Technical Data Definitions ITU-Scope-Constitution-Convention-Radio-Regulations-WRC-Quadrennial-Treaty-Art1-Definitions ITU Constitution + Convention + Radio Regulations Scope + Article 1 Definitions + Article 2 Nomenclature + WRC World Radiocommunication Conference Quadrennial Treaty Process + Member States + Sector Members BIPA-SEC5-1 Biometric Identifier Definition RBI-AA-Ecosystem-FIPs-FIUs-Interoperability-Onboarding-Sahamati-DPI-IndiaStack RBI AA Ecosystem - Financial Information Providers (FIPs) + Financial Information Users (FIUs) + Interoperability + Sahamati SRO Onboarding + DPI India Stack + Cross-Sector Regulators ItalyCodice-DataSubjectRights-Limitations-Deceased-Minors-14-Years-Italian-2undecies-2duodecies-2terdecies Italy Codice Data Subject Rights + Article 2-undecies Limitations + Article 2-duodecies Deceased Persons Rights + Article 2-terdecies Minors Rights (14 Years Consent Age) + GDPR Articles 15-22 + Italian Civil Procedure Remedies MAS-TRM-Governance-Chapters-2-3-Board-Senior-Management-Risk-Framework-Information-Asset-Management MAS TRM Governance + Chapters 2-3 + Board + Senior Management + Risk Framework + Information Asset Management NAIC-1 NAIC Model Law Adoption, Scope, and Licensee Definitions AQAP2110-3 Design and Development Control - NATO plus ISO 13485 Cross-Walk PQC-4 FIPS 205 SLH-DSA Implementation - Stateless Hash-Based Digital Signature NISTSP115-1 Scope, Methodology, and Assessment Planning NISTSP137-1 ISCM Strategy, Governance, and Volatility Assessment NISTSP144-1 Cloud Governance, Risk Assessment, and Provider Trust Evaluation NISTSP145-7 Cloud Procurement Standards Aligned to NIST SP 800-145 Definition NISTSP146-1 Cloud Adoption Strategy, Workload Suitability, and Decision Framework NISTSP61-2 Computer Security Incident Response Team (CSIRT) Structure and Staffing NISTSP63R4-1 Digital Identity Risk Management and IAL/AAL/FAL Assurance Level Selection NISTSP88-1 Media Sanitization Policy, Roles, and Decision Framework NISTSP92-1 Log Management Programme, Policy, Roles, and Operational Runbooks AUNDB-A3 Eligible Data Breach Determination and Serious Harm Threshold OCCHS-1 Scope, Applicability, and Definitions of Heightened Standards OSFIB13-1 Governance, Risk Management, and Three Lines of Defense OWASPASVS-1 Architecture, Design and Threat Modelling (V1) OPENBANK-2 Strong Customer Authentication (SCA), Consent Lifecycle, and Customer UX OSSFSC-1 Branch Protection, Code Review, and Repository Governance 2.2.2 2.2.2 Vendor default accounts managed PCI-P2PE-05 Roles and responsibilities definition PCI-PIN-05 Roles and responsibilities definition PCI-SSF-05 Roles and responsibilities definition PSDTWO-1 Strong Customer Authentication (SCA) Core Requirements PTESPHASE-1 Pre-Engagement Interactions and Scoping PSPF24-1 Security Culture, Governance, Risk Management SWIFTCSCF-1 Restrict Internet Access and Protect Critical Systems (Objective 1) IM8-RES.2 Disaster Recovery ISMSP-SYS-04 Vulnerability Management FADP-5 Definitions (Article 5) UKBRIBE-3 Due Diligence on Third Parties OB-OPS.2 Performance Standards 15 U.S.C. § 78dd-2(h) Definition of Domestic Concern USMCADIGITAL-1 Cross-Border Data Flows and Localisation VIETNAMCYBER-2 Prohibited Acts (Access, Interception, Forgery, Content) W3CVCDM-1 Three-Party Ecosystem (Issuer, Holder, Verifier) Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected .
Query this from an agent The graph holds this control, the 220 it maps to, and the evidence behind each claim, over MCP and REST.