H WHO Guidelines H WHO Guidelines
as of 2019 - 05 - 07
H.3 WHO guidelines on quality risk management (Technical Report Series, No. 981 (2013), Annex 2)
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
Further reading
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