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 WHO Good Manufacturing Practices.
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.
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 WHO Good Manufacturing Practices.
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.
