TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9

TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9

TABLE OF CONTENTS

1. INTRODUCTION…………………………………………………………………………………………………1
2. SCOPE………………………………………………………………………………………………………………..2
3. PRINCIPLES OF QUALITY RISK MANAGEMENT…………………………………………………2
4. GENERAL QUALITY RISK MANAGEMENT PROCESS…………………………………………..2
4.1 Responsibilities ………………………………………………………………………………………………… 3
4.2 Initiating a Quality Risk Management Process ……………………………………………………. 3
4.3 Risk Assessment……………………………………………………………………………………………….. 3
4.4 Risk Control……………………………………………………………………………………………………… 4
4.5 Risk Communication…………………………………………………………………………………………. 5
4.6 Risk Review……………………………………………………………………………………………………… 5
5. RISK MANAGEMENT METHODOLOGY ………………………………………………………………5
6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO THE INDUSTRY
AND REGULATORY OPERATIONS …………………………………………………………………………6
7. DEFINITIONS……………………………………………………………………………………………………..7
8. REFERENCES…………………………………………………………………………………………………….9
Annex I: Risk Management Methods and Tools…………………………………………………………11
I.1 Basic Risk Management Facilitation Methods……………………………………………………… 11
I.2 Failure Mode Effects Analysis (FMEA)……………………………………………………………….. 11
I.3 Failure Mode, Effects and Criticality Analysis (FMECA)……………………………………….. 11
I.4 Fault Tree Analysis (FTA) …………………………………………………………………………………. 12
I.5 Hazard Analysis and Critical Control Points (HACCP)…………………………………………. 12
I.6 Hazard Operability Analysis (HAZOP) ………………………………………………………………. 13
I.7 Preliminary Hazard Analysis (PHA) ………………………………………………………………….. 13

I.8 Risk Ranking and Filtering ………………………………………………………………………………. 13
I.9 Supporting Statistical Tools………………………………………………………………………………. 14
Annex II: Potential Applications for Quality Risk Management…………………………………..15
II.1 Quality Risk Management as Part of Integrated Quality Management …………………. 15
II.2 Quality Risk Management as Part of Regulatory Operations ………………………………. 16
II.3 Quality Risk Management as Part of development……………………………………………… 16
II.4 Quality Risk Management for Facilities, Equipment, and Utilities………………………… 17
II.5 Quality Risk Management as Part of Materials Management………………………………. 18
II.6 Quality Risk Management as Part of Production ……………………………………………….. 19
II.7 Quality Risk Management as Part of Laboratory Control and Stability Studies …….. 19
II.8 Quality Risk Management as Part of Packaging and Labelling…………………………….. 19

Reference –  ICH, QUALITY RISK MANAGEMENT, Q9 -09 November 2005

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