Quality Control Laboratories

Medicines quality control laboratories (QCLs) play a vital role in testing and verifying that finished pharmaceutical product (FPPs) continue to meet international standards of quality  and safety,  and if and when they fail to do so, alerting regulators, procurers and manufacturers of the need for corrective action. 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. But it can only be carried out successfully if the relevant QCL is operating at international standards. A WHO-prequalified QCL is just such a lab: its services can be used with confidence.

To become prequalified a QCL must be able to demonstrate that it adheres to 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 those QCLs for which prequalification represents a significant challenge, technical assistance can be made available, provided the QCL is committed to improving its capacity, expertise and skills. QCLs can also participate in WHO training activities which include not only conventional workshops but also a mutual audit scheme whereby QCLs identify gaps in their technical competence and/or activities, and work towards eliminating these.

Once they have become prequalified, QCLs 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.

The sections of this website of most interest and relevance to QCLs are:

  • Procedures and Fees — what QCLs must do in order to become prequalified, including the standards  they must meet
  • WHO List of Prequalified QCLs — giving information on the QCLs that have been prequalified to date, including the area of expertise evaluated and considered prequalified
  • WHO List of Prequalified Medicinal Products — what FPPs have been prequalified and when, in what therapeutic area, dosage, form and strength; and where manufactured
  • WHO List of Prequalified Active Pharmaceutical Ingredients — what APIs have been prequalified and when; where; with what packaging, re-test period or shelf life and storage conditions
  • Quality Monitoring — how quality monitoring projects are structured and the projects completed to date
  • Monitoring QCL Performance — what prequalified QCLs must do to maintain their  prequalified status
  • WHO Public Inspection Reports — these are issued for QCLs (manufacturing sites and contract research organizations) that pass WHO inspection
  • Technical Assistance — the support available to QLCs to help them overcome the challenges they face in working towards prequalification
  • Guidance Documents — WHO guidelines underpin WHO medicines prequalification and define the requirements that must be met while The International Pharmacopoeia gives quality specifications for selected pharmaceutical products, excipients and dosage forms
  • Key Contacts — the key persons who can be contacted regarding different aspects of prequalification or for technical assistance.