Transcription of Deviation Handling and Quality Risk Management
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Deviation Handling and Quality Risk Management
Deviation Handling and Quality Risk Management A note for guidance for the manufacture of prequalified vaccines for supply to United Nations agencies July, 2013 Vaccine Quality and Regulations (VQR), Essential Medicines and Health Products World Health Organization (WHO), Geneva, Switzerland Deviation Handling and Quality Risk Management 2 This guidance document Deviation Handling and Quality Risk Management is one of a series developed by WHO/EMP/HIS Quality , Safety & Standards team upon request from the manufacturers members of the Developing Countries Vaccine Manufacturers Network (DCVMN), with funds of USAID.
Quality Risk Management was mainly designed to be used prospectively when manufacturing operations are defined and validated. Therefore, potential deviations are identified and avoided ... category. Deviations should require a higher level of analysis and documentation, and are usually covered by a deviation handling procedure. At this point, a ...
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