Transcription of Annex 2
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Annex 2
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. Responsibilities 76. QRM application during product development 77. QRM application during validation and quali cation 78. QRM application during commercial manufacturing 79. QRM integration with key quality system elements 79.
Annex 2 65 The level of effort, formality and documentation of the QRM process should be commensurate with the level of risk. In addition to the two principles above, the following principles are also part of the QRM methodology:
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