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. A set of priority topics has been identified by vaccine manufacturers for WHO to provide guidance on expectations from the vaccine prequalification programme.
applicable and as possible on the impact (or hazard) and risk on the process and product quality by the use of any QRM tool. The use of one of these tools is described in section 5.3. Minor Deviations When the deviation does not affect any quality attribute, a …
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