TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9 IN PHARMA

TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9 IN PHARMA

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

About Abha Maurya

Abha is the Author of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in the pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, and Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008, and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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