WHO TRS 981, 2013 Annex 2

WHO TRS (Technical Report Series) 981, 2013 Annex 2

WHO Guidelines On Quality Risk Management

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TABLE OF CONTENTS

1. Introduction 

1.1 Background and scope 

1.2 Principles of quality risk management 

2. Glossary 

3. Quality risk management process

3.1 Initiating a QRM process 

3.2 Personnel involved in QRM 

3.3 Knowledge of the product and process 

3.4 Risk assessment 

3.5 Risk control 

3.6 Risk review 

3.7 Verification of QRM process and methodologies 

3.8 Risk communication and documentation 

4. QRM application for pharmaceuticals 

4.1 Training and education 

4.2 Responsibilities 

4.3 QRM application during product development 

4.4 QRM application during validation and qualification 

4.5 QRM application during commercial manufacturing 

4.5.1 QRM integration with key quality system elements 

4.5.2 QRM application in product manufacturing operations 

5. QRM considerations for medicines regulatory authorities 

5.1 Introduction 

5.2 QRM application to inspection strategy 

5.2.1 Risk management in inspections 

5.2.2 Inspection planning and conduct 

5.2.3 Corrective action and preventive action review, and scheduling of

routine inspections 

5.2.4 Complaint handling and investigation 

5.3 Inspection of QRM at a manufacturing site 

5.4 QRM applied to dossier review (assessment) 

6. Risk management tools 

References 

WHO TRS (Technical Report Series) 981, 2013 Annex 2: