On 21 October the WHO started a pilot programme for the pre-qualification of pharmaceutical APIs and invited all API manufacturers to participate. This pilot programme completes the already existing pre-qualification programme for medicinal products, in which - among other things - the API Master File is evaluated as well. Only if a risk analysis suggests a GMP inspection in the API manufacturing site, it is conducted. The new pilot programme also comprises a review of the API dossiers and, in any case, an on-site GMP inspection.
The pre-qualified APIs are included in a list. This list is certainly very interesting for medicinal product manufacturers and national authorities as it provides direct information about the standard of manufactured APIs - meaning the confirmation of compliance with the WHO GMP regulations.
The pilot programme does not cover all APIs, though. It is solely limited to APIs for the manufacture of the three most important and most prevalent infection diseases: HIV/AIDS, Malaria and Tuberculosis.
Companies that would like to have their medicinal products for the mentioned diseases pre-qualified through the existing WHO programme, will most likely receive this qualification very quickly, if they already use pre-qualified APIs. Companies participating in the new pilot programme would therefore have a competitive advantage. The programme's contribution is especially important, though, as it ensures GMP standards of pre-qualified APIs and security aspects of the supply chain.
To find further information on the introduction and a more detailed description as well as further important documents, please see the pre-qualification programme.
Dr. Gerhard Becker
On behalf of the European Compliance Academy (ECA)