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 ... conformities; defining when and how corrections, corrective actions, or preventive actions should be undertaken. ... - Operational parameter out of range for a parameter defined as non-critical. - Untrained personnel responsible for segregating the approved and rejected raw material
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