Medicines Quality Control Laboratories
WHO prequalification of a quality control laboratory (QCL) consists of:
- assessment of a laboratory information file or quality manual
- on-site inspection.
Assessment of laboratory information
The laboratory information provided is assessed to ascertain whether WHO Good Practices for Quality Control Laboratories, WHO Good Practices for Pharmaceutical Microbiological Laboratories, and the relevant parts of Good Manufacturing Practices as recommended by WHO for such laboratories (relating to transfer of technology in pharmaceutical manufacturing (analytical method transfer), validation, sterile pharmaceutical products, heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms and water for pharmaceutical use) are being adhered to.
Inspection
If the results of the assessment are positive, the QCL is recommended for inspection, to assess compliance with WHO-recommended standards for QCLs.
Invitation to submit an expression of interest
Guidance
Guidelines for preparing a laboratory information file (2011)
Directives pour la preparation d'un dossier d'information par le laboratoire (2011)
Good practices for pharmaceutical quality control laboratories
WHO good practices for pharmaceutical quality control laboratories (2010)
Régles de bonne pratique applicables par les laboratoires de contrôle qualité pharmaceutique (2010)
Boas práticas da OMS para laboratórios de controle de qualidade de produtos farmacêuticos (2010)
Buenas prácticas de la OMS para laboratorios de control de calidad de productos farmacéuticos (2010)
Good practices for pharmaceutical microbiology laboratories
Buenas prácticas de la OMS para laboratorios de microbiología farmacéutics (2011)
Good practices for pharmaceutical microbiology laboratories (2011)
Good manufacturing practices relevant to QCLs
Guidelines on transfer of technology in pharmaceutical manufacturing (2011)
Good manufacturing practices: validation (2019)
Good manufacturing practices: sterile pharmaceutical products (2011)
Good manufacturing practices for pharmaceutical products: main principles (2014)
Good manufacturing practices: water for pharmaceutical use (2012)
Additional guidance
Model certificate of analysis (2018)
WHO guidance on testing of “suspect” falsified medicines (2018)
Guide to good storage practices for pharmaceuticals (2003)
Guidelines for sampling of pharmaceutical products and related materials (2005)
Considerations for requesting analyses of medicines samples (2018)
Training materials
Quality control laboratory training modules
WHO guidelines on transfer of technology in pharmaceutical manufacturing
Annex 7, WHO Technical Report Series 961, 2011