Medicines Quality Control Laboratories

WHO prequalification of a quality control laboratory 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. Alternatively, the QCL may submit the report of an inspection or audit performed  by a regulatory authority that applies standards at least equivalent to WHO-recommended quality standards for quality control laboratories referred to above, and its response to any observations made by the authority during inspection or  audit. The inspection may then be waived.

Invitation to submit an expression of interest

Quality control laboratories


Guidelines

Guidelines for preparing a laboratory information file (2011)

Directives pour la préparation d'un dossier d'information par le laboratoire (2011)

Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies (2011)

Procédure de préqualification (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 farmacéutica

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 (2006)

Good manufacturing practices: sterile pharmaceutical products (2011)

Good manufacturing practices: heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (2011)

Good manufacturing practices for pharmaceutical products: main principles (2014)

 Good manufacturing practices: water for pharmaceutical use (2012)


Additional guidelines

Model certificate of analysis

General guidelines for the establishment, maintenance and distribution of chemical reference substances

Guide to good storage practices for pharmaceuticals

Guidelines for sampling of pharmaceutical products and related materials

Considerations for requesting analyses of drug samples


Training materials

Quality control laboratory training modules