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ICHQ3D and Finished Pharmaceutical Products (FPPs) prequalification procedures PDF

Guideline/guidance

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IVD

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VCP

Impact assessment of WHO prequalification and systems supporting activities (June 2019) PDF

Report

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Information on the GMP status of Micro Labs Kumbalgodu (ML08) manufacturing facility PDF

Information note

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Interagency finished pharmaceutical products questionnaire DOCX

Guideline/guidance

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Investing in WHO medicines prequalification: is it worth it? (2013) (in Chinese)

Advocacy material

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Investing in WHO prequalification of finished pharmaceutical products

Advocacy material

Recently Updated Documents

Notes on the design of bioequivalence study: pyrimethamine

External Guidance - FPP Assessment Application Wizard Guidance

Quality & BE Assessment Training for AMA affiliated assessors Agenda

PQS Application Review Template for E008 AD syringe V1.0 21JUL2025

PQS Application Review Template for E013 RUP syringe V1.0 21JUL2025

WHO Technical Report Series Location

WHO Technical Report Series documents relating to development, production, distribution, inspection and quality control of medicines can be found in the guidelines section of the WHO web pages dealing with quality assurance of medicines. The guidelines most relevant to WHO medicines prequalification are listed and accessible on the WHO Technical Report Series page.