Capacity Building for Quality Control Laboratories
WHO has developed a peer audit system within the network of QCLs involved in WHO prequalification. Through peer audits QCLs can identify gaps in their technical competence and/or activities, and work towards eliminating these. Peer audits also provide training opportunities for QCL auditors. Further information or a request to participate in a mutual audit can be sent to prequallaboratories@who.int.
Training workshops for regulators, manufacturers and QCL staff
WHO organizes training workshops for regulators and for manufacturers. Topics are varied but may cover regulatory data requirements, assessment, principles and specific requirements relating to Good Manufacturing Practices, Good Clinical Practices and/or Good Laboratory Practices, WHO’s Collaborative Registration Procedures, pharmaceutical development and WHO prequalification requirements. Some workshops are organized for a combined audience of regulators and manufacturers since each group can find it informative to better understand the perspectives and challenges in regulation or manufacturing of the other group.
Training workshops are generally by invitation only, but workshop PowerPoint presentations are made publicly available on the Events section of this website. (WHO training modules on GMP and QCL topics can also be of great value when seeking to improve staff competencies.)
Organization of specialized technical assistance for manufacturers, CROs and QCLs
WHO provides technical assistance to help recipients develop the capacity to achieve compliance with international regulatory norms and standards, so that they can attain WHO prequalification for priority products or services. It is available for:
- manufacturers who produce or plan to produce priority APIs or FPPs, as listed on current Invitations to Manufacturers to Submit for Product Evaluation
- CROs that conduct or plan to conduct clinical studies for FPPs listed on current Invitations to Manufacturers to Submit for Product Evaluation
- national QCLs that conduct or plan to conduct quality control testing for of priority FPPs, as listed on current Invitations to Manufacturers to Submit for Product Evaluation.