Quality Control Laboratories for Medicines

This list of WHO prequalified medicines quality control laboratories, contains laboratories which have expressed their interest to participate on a voluntary basis in the World Health Organization (WHO) prequalification procedure, have been assessed as part of the WHO Prequalification Programme and found to comply with standards recommended by WHO.

• WHO ensures compliance with Good Practices for National Pharmaceutical Control Laboratories (GPCL) and relevant parts of WHO Good Manufacturing Practices (GMP) at the quality control laboratories prior to listing them as being prequalified. The initial assessment involves a review of the documentation provided by the laboratory and an inspection.
• WHO inspections are done by a team of inspectors including: 1. An inspector/expert from one of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) countries 2. A WHO representative (inspector / expert) 3. An inspector (or inspectors) as an observer from the National Drug Regulatory Authority of the country, in which the laboratory is located, subject to their availability at the time and as relevant.
• Observations listed in the inspection reports should be addressed to a satisfactory level of compliance by the laboratories prior to listing in the list of prequalified laboratories. The corrective actions taken by the laboratories are assessed through documentation review and follow-up inspections when these are required.
• WHO Public Inspection Reports (WHOPIRs) are published on this web page for laboratories found to be meeting WHO norms and standards. A WHOPIR provides a summary of the initial inspection report.

After being accepted as a prequalified medicines quality control laboratory, the laboratories need to provide each year their annual report and their laboratory information file (LIF). The successful review of this documentation is a prerequisite to maintain the status of a WHO prequalified medicines quality control laboratory. Failure to provide this documentation and/or indications of non-compliance with WHO standards result in delisting. The list provided here below is kept up to date.

For ease of use the list can be sorted according to WHO regions and or according to country.

Only laboratories meeting the above standards are included in the list.