Transcription of Annex 2 - WHO
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Annex 2 - WHO
Annex 2. WHO guidelines on quality risk management 1. Introduction 62. Background and scope 62. Principles of quality risk management 64. 2. Glossary 67. 3. Quality risk management process 70. Initiating a QRM process 70. Personnel involved in QRM 70. Knowledge of the product and process 71. Risk assessment 71. Risk control 72. Risk review 73. Veri cation of QRM process and methodologies 74. Risk communication and documentation 75. 4. QRM application for pharmaceuticals 76. Training and education 76.
WHO Technical Report Series No. 981, 2013 WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report – Manufacturers: evaluation of quality risk through science-based decisions can be linked ultimately to protection of the patient by ensuring the quality, safety and efficacy of the product. A corporate
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