Module 9 2021

23/03/2021

WHO Prequalification (Vaccines) General principles

Priority vaccines defined by WHO Reliance on the National Regulatory Authority (NRA) of country of manufacture

 NRA meets WHO indicators  Registered vaccine (MA granted)  PQ process: NRA Informed and involved

Vaccine meets Programmatic Suitability (PSPQ) requirements ● these include: preservative content, thermostability, route of administration, vaccine vial monitor, cold storage Random testing by WHO-contracted laboratories Monitoring of complaints from the field

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Specific Processes Used by Vaccines

Control Authority Release System

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