API firms stand to gain by seeking prequalification says the WHO

By Gareth Macdonald

- Last updated on GMT

API firms stand to gain by seeking prequalification says the WHO
API firms stand to gain by seeking prequalification says the WHO

Related tags Pharmaceutical drug Manufacturing

Persuading API manufacturers to seek prequalification is a challenge according to the WHO, which wants to raise awarness about the process and the positive impact it has on a suppliers' reputation.

The World Health Organisation (WHO) began prequalifying drug suppliers in 2001 in an effort to ensure HIV/AIDS, malaria and TB medicines sourced by national procurement agencies were of appropriate quality. The scheme has been expanded to all drugs on its essential medicines list​.

The active pharmaceutical ingredient (API) prequalification process grew out of this according to Antony Fake, API assessment focal point, who told us it became apparent that prequalified finished product firms often found it problematic to identify quality ingredient sources.

API prequalification publicly identifies sources of API that meet quality standards and are manufactured in compliance with WHO good manufacturing practice​” Fake said, explaining that this information is made available to manufacturers.

The procedure operates independently of FPP manufacturers but in parallel with the FPP PQ process.  Of course, when it comes to FPP prequalification we prefer the use of a prequalified API, but it is important to understand that this is not mandatory​.”

API suppliers named by drugmakers seeking prequalification must be either prequalified, hold a European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificate of Suitability (CEP) or be able to provide an active pharmaceutical ingredient master file (APIMF).

Prequalification process

Recruiting API suppliers is a big focus for the WHO and – according to Fake – still difficult.

Although API manufacturers have responded very positively to API prequalification, encouraging them to submit an application for prequalification remains a challenge​” he said, adding that some lack experience of stringent regulatory standards and are unable to meet WHO PQ standards.

He explained that the process consists of review of the API manufacturer’s APIMF and a review of the GMP standard to which the ingredient involved is being manufactured, adding that site inspection is not always required.

“With respect to GMP, WHO collaborates extensively with other inspectorates. Therefore, if the GMP status of the manufacture can be established, based upon the review of another authority’s inspection reports, inspection may not be necessary. 

Of course, where the GMP standard cannot be determined the WHO must inspect the manufacturing site.  WHO PQ inspections are in line with published WHO GMP requirements which are closely aligned with ICH GMP requirements​.”

Fake went on to say that the WHO also tries to convince API firms to seek prequalification by stressing the benefits such status can have for the firm involved.

The reasons why API manufacturers apply for API prequalification vary and are not strictly related to their current commercial supply arrangements.​ 

I think it is fair to say that being API-prequalified for established manufacturers enhances their reputation and public standing, whereas for other less established manufactures it serves as a very effective means for raising their overall quality and GMP standards​.”

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