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Annex 2 - World Health Organization

61 Annex 2 WHO guidelines on quality risk management1. Introduction Background and scope Principles of quality risk management 642. Glossary 673. Quality risk management process Initiating a QRM process Personnel involved in QRM Knowledge of the product and process Risk assessment Risk control Risk review Verification of QRM process and methodologies Risk communication and documentation 754. QRM application for pharmaceuticals Training and education Responsibilities QRM application during product development QRM application during validation and qualification QRM application during commercial manufacturing QRM integration with key quality system elements QRM application in product manufacturing operations 805.

Annex 2 63 While the choice of the tools to support the QRM approach is optional and may vary, the tools chosen need to be appropriate for the intended use.


  Health, World health organization, World, Organization, Annex, Annex 2




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