Transcription of WHO GUIDELINE ON QUALITY RISK MANAGEMENT
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Working document August 2012 RESTRICTED WHO GUIDELINE ON QUALITY RISK MANAGEMENT REVISED DRAFT FOR COMMENT World Health Organization 2012 All rights reserved. This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations' concerned staff and member organizations) without the permission of the World Health Organization.
QRM is the overall and continuing process of appropriately managing risks to product quality throughout its life-cycle in order to optimize its benefit/risk balance. It is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and ...
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