Module 9 2024

03/09/2024

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

The Organisation for Professionals in Regulatory Affairs

91

Specific Processes Used by Vaccines

Control Authority Release System

The Organisation for Professionals in Regulatory Affairs

92

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