The approval represented by inclusion of a finished pharmaceutical product (FPP) in the WHO List of Prequalified Medicinal Products, of an active pharmaceutical ingredient (API) in the WHO List of Prequalified Active Pharmaceutical Ingredients, or of a quality control laboratory (QCL) in the WHO List of Prequalified Quality Control Laboratories, is not valid indefinitely and must be actively maintained.
FPPs: As well as continuing to meet prequalification requirements on an ongoing basis, FPPs are subject to requalification. All FPPs are subject to requalification after five years. Additionally, in the event of notification of a product complaint, PQTm will generally carry out further product assessment and possibly also inspect the manufacturing site(s). And to verify that the quality of prequalified products is being maintained, WHO carries out random quality control testing of prequalified FPPs that have been supplied to countries.
APIs: Prequalified APIs are not subject to requalification but certain requirements must be met if prequalification status is to be retained. Holders of prequalified APIs must ensure the accuracy of the information contained in the API master file and:
- provide all necessary documents to WHO to demonstrate that any change will not or has not had a negative effect on the API’s quality or safety
- communicate information about any changes made to the API to FPP manufacturers who manufacture FPPs with that API.
QCLs: Although prequalified QCLs do not undergo requalification at any stage, ongoing monitoring of the activities of prequalified QCLs is carried out. This includes reinspection at regular intervals (at least once every three years), evaluation of results from participation in an appropriate proficiency testing scheme, and monitoring and investigation of complaints concerning the results of analysis or service provided by the listed laboratories. To facilitate the monitoring each prequalified laboratory is requested to submit a brief annual report on its activities related to quality control of medicines