Performance Evaluating Laboratories

Independent laboratory performance evaluation of in vitro diagnostics (IVDs) enables WHO to verify certain standards of performance that are considered essential for resource-limited settings. For a laboratory to successfully prequalify as a WHO evaluating laboratory, it must meet international standards for testing of specified IVDs. Such laboratories significantly contribute to WHO's aim to increase access to IVDs for accurate diagnosis and monitoring of priority disease and conditions and are considered as key partners for WHO prequalification.

WHO requirements for listing of a prequalification evaluating laboratory are specifically related to performance evaluations. An assessment will ascertain the potential for a laboratory to undertake a performance evaluation according to the relevant WHO protocol, as well as the laboratory’s compliance with the principles of ISO/IEC 17025:2017 and ISO 15189:2012. The auditing process is based on the principles outlined in ISO 19011:2018.

More information about performance evaluating laboratories, relevant audits and laboratory responsibilities can be found at:

• Performance evaluating laboratories

Quality Control Laboratories

Medicines quality control laboratories (QCLs) play a significant role in testing and verifying that finished pharmaceutical products (FPPs) continue to meet international standards of quality, safety and efficacy.  This role is especially important when the FPPs concerned are imported or produced locally for treating life-threatening diseases, or promoting maternal and child health, in vulnerable populations and it can only be carried out successfully if the relevant QCL is operating according to international standards and norms.

To become prequalified for chemical and microbiological testing, a QCL must be able to demonstrate that it adheres to:

• WHO Good Practices for pharmaceutical quality control laboratories
• WHO Good Practices for Pharmaceutical Microbiological Laboratories

Once a medicines laboratory is prequalified, it may be invited to participate in WHO prequalification monitoring projects that are undertaken periodically to assess the quality of medicines procured by UN agencies. Each monitoring project focuses on a particular therapeutic area and medicines assessed include both WHO-prequalified and non-WHO prequalified medicines.

Further information on prequalification and inspection of QCLs can be found at:

• Medicines quality control laboratories
• Inspection of quality control laboratories

National Control Laboratories

WHO vaccines prequalification relies on national regulatory authorities (NRAs) deemed “functional”, or that have been WHO-listed as operating at a minimum of maturity level 3. One of the criteria for such NRAs is that they operate a national control laboratory (NCL) that can perform lot release testing of prequalified vaccines. Quality control testing of vaccines is a challenging task requiring resources and technical expertise. To help optimize use of these resources and expertise, WHO created the WHO-National Control Laboratory Network for Biologicals (WHO-NNB). WHO-NNB provides a platform for exchange of quality and technical information on prequalified vaccines to facilitate access to vaccines: through recognition by recipient countries of the lot release of the responsible national regulatory authority (NRA). This cooperation and networking help ensure efficient testing, save costs and reduce the risk of inaccurate results. The network also promotes development of harmonized common standards and best practice, supports test harmonization and NCL strengthening through technical assistance, the design and application of harmonized test methodologies, the organization of collaborative studies, and confidential sharing of lot release results (based on manufacturers’ consent).

Additional information on this website for NCLs:

• National Control Laboratories