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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.

system, and it largely depends on their level of training, qualification, commitment, and support form upper management. Deviation Handling and Quality Risk Management 6 As a basic requirement, personnel are expected to be alert and aware of possible undesirable

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