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One-third of antimalarial medicines tested in six African countries fail to meet international quality standards (issued 25 February 2011) PDF

Information note

Outline of the content of an annual report on the activities of a prequalified quality control laboratory (QCL) (4 June 2016) PDF

Guideline/guidance

Oxytocin injection - Clarification of stability data and storage statement requirements PDF

Guideline/guidance

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.