ICH Q10 - Pharmaceutical Quality System
ICH Q10 Scope + ICH Family Coordination

ICH Q10 - Pharmaceutical Quality System 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

What does ICH-Q10-Scope-PQS-ICH-Q8-Q9-Q11-Q12-ISO9001-GMP-Coord require?

ICH Q10 Pharmaceutical Quality System (PQS) - ICH Harmonised Tripartite Guideline (Current Step 4 version dated 4 June 2008). Provides a model for an effective quality management system for the pharmaceutical industry covering the product lifecycle. Three main objectives: achieve product realisation + establish and maintain a state of control + facilitate continual improvement. The guideline applies to the full product lifecycle from pharmaceutical development through commercial manufacturing to product discontinuation - covering active pharmaceutical ingredients (API) + drug products + biological products + biotechnological products. ICH Q10 is intentionally aligned with ISO 9001 quality management system concepts and complements GMP regional requirements (FDA 21 CFR Part 210/211 + EU EudraLex Volume 4 + PMDA GMP). Coordinates with ICH Q8 (Pharmaceutical Development - quality by design QbD + design space + control strategy + critical quality attributes CQAs); ICH Q9 (Quality Risk Management - risk identification + analysis + evaluation + control + review + risk-based decision-making); ICH Q11 (Development and Manufacture of Drug Substances); ICH Q12 (Lifecycle Management - established conditions + post-approval change management); ICH Q13 (Continuous Manufacturing); ICH Q14 (Analytical Procedure Development). Implementation by FDA (CDER + CBER + ORA) + EMA (CHMP + CMDh) + PMDA + Health Canada + Swissmedic + ANVISA + NMPA China + CDSCO India + WHO Prequalification. Q10 PQS = ICH Q8 + Q9 + Q10 trinity (Quality by Design + Risk Management + Quality System). The guideline is freely distributable + public ICH publication. ICH Q10 + Scope + PQS + ICH family + ISO 9001 + GMP coordination applies.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 24 controls across 12 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

Aged Care Quality Standards 2019 (repealed edition) · 3 controls

  • ACQS-3-1 Safe and Effective Care
  • ACQS-8-2 Clinical Governance
  • ACQS-8-4 Risk Management

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence · 3 controls

  • ISO-15189-5.6 Risk management
  • ISO-15189-7.4 Post-examination processes
  • ISO-15189-8.4 Control of records

MDS2 (Medical Device) · 3 controls

  • 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

Regulation on the European Health Data Space (EHDS) · 3 controls

  • 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

COSO Internal Control - Integrated Framework (2013) · 2 controls

  • CA-10 Selects and Develops Control Activities
  • CA-12 Deploys Through Policies and Procedures

Florida Digital Bill of Rights (FDBR) · 2 controls

  • FDBR-704 Exemptions (§501.704)
  • FDBR-Scope-Defs Scope, Applicability Thresholds and Definitions (Fla. Stat. 501.701, 501.702, 501.703, 501.704)

TEFCA - Trusted Exchange Framework and Common Agreement · 2 controls

  • TEFCAREC-1 Common Agreement Conformance and Onboarding
  • TEFCAREC-2 Privacy, Security, Minimum Necessary

FDA Quality Management System Regulation (QMSR) · 1 control

  • QMSR-820.10 Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)

IEC 60601-1 - Medical Electrical Equipment Safety · 1 control

  • 60601-1.12 Accuracy of controls and instruments

NAIC Insurance Data Security Model Law (MDL-668) · 1 control

  • NAIC-1 NAIC Model Law Adoption, Scope, and Licensee Definitions

NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production · 1 control

  • AQAP2110-3 Design and Development Control - NATO plus ISO 13485 Cross-Walk

PIC/S Guide to Good Manufacturing Practice for Medicinal Products · 1 control

  • PICSGMP-1 Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management

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 24 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll ICH Q10 - Pharmaceutical Quality System controls