ICH Guideline Q10 Pharmaceutical Quality System
Channel: DR Technical Gyan
Date: 2020-12-21

1. ICH Guideline Q10 Pharmaceutical Quality System
1.1 Introduction
1.2 Scope
1.3 Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards and ICH Q7
1.4 Relationship of ICH Q10 to Regulatory Approaches
1.5 ICH Q10 Objectives
1.5.1 Achieve Product Realisation
1.5.2 Establish and Maintain a State of Control
1.5.3 Facilitate Continual Improvement
1.6 Enablers: Knowledge Management and Quality Risk Management
1.6.1 Knowledge Management
1.6.2 Quality Risk Management
1.7 Design and Content Considerations
1.8 Quality Manual
2. MANAGEMENT RESPONSIBILITY
2.1 Management Commitment
2.2 Quality Policy
2.3 Quality Planning
2.4 Resource Management
2.5 Internal Communication
2.6 Management Review
2.7 Management of Outsourced Activities and Purchased Materials
2.8 Management of Change in Product Ownership
3. CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY
3.1 Lifecycle Stage Goals
3.1.1 Pharmaceutical Development
3.1.2 Technology Transfer
3.1.3 Commercial Manufacturing
3.1.4 Product Discontinuation
3.2 Pharmaceutical Quality System Elements
3.2.1 Process Performance and Product Quality Monitoring System
3.2.2 Corrective Action and Preventive Action (CAPA) System
3.2.3 Change Management System
3.2.4 Management Review of Process Performance and Product Quality
4. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM
4.1 Management Review of the Pharmaceutical Quality System
4.2 Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System
4.3 Outcomes of Management Review and Monitoring
5. GLOSSARY
Annex 1:Potential Opportunities to Enhance Science and Risk Based Regulatory Approaches 
Annex 2:Diagram of the ICH Q10 Pharmaceutical Quality System Model