ICH Q10-Pharmaceutical Quality System-Sept 2

Description

ICH Q10-Pharmaceutical Quality System-Sept 2

PHARMACEUTICAL QUALITY SYSTEM
Draft ICH Consensus Guideline
Released for Consultation on 9 May 2007, at Step 2 of the ICH Process

TABLE
OF CONTENTS
1. PHARMACEUTICAL QUALITY SYSTEM.......................1
1.1 Introduction.....1
1.2 Scope.................1
1.3 Relationship of ICH Q10 to Regional GMP Requirements,
ISO Standards and ICH Q7....2

1.4 Relationship of ICH Q10 to Regulatory Approaches.............2
1.5 ICH Q10 Objectives.................2
1.6 Enablers...........3
1.7 Design and Content Considerations...............3
1.8 Quality Manual........................4
2. MANAGEMENT RESPONSIBILITY.........4
2.1 Management Commitment.....4
2.2 Quality Policy...........................4
2.3 Quality Planning .....................5
2.4 Resource Management............5
2.5 Internal Communication.........5
2.6 Management Review...............5
2.7 Oversight of Outsourced Activities.................5
3. CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE
AND PRODUCT QUALITY.........................6

3.1 Lifecycle Stage Goals...............6
3.2 Pharmaceutical Quality System Elements....7
4. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL
QUALITY SYSTEM.............12

4.1 Management Review of the Pharmaceutical Quality System.....................12
4.2 Monitoring of Internal and External Factors Impacting the
Pharmaceutical Quality System...................12

4.3 Outcomes of Management Review and Monitoring.............12
5. GLOSSARY...........................13
Annex 1 ¨C Potential Opportunities to Enhance Science and
Risk Based Regulatory Approaches...........15

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