WHO Technical Report Series, No. 981 - World Health Organization
WHO Technical Report Series, No. 981 - World Health Organization
WHO Technical Report Series, No. 981 - World Health Organization
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10. Prequalification of active pharmaceutical ingredients<br />
10.1 Update on the prequalification of active<br />
pharmaceutical ingredients<br />
The prequalification of APIs began in October 2010 as a pilot project intended<br />
to identify APIs that are of good quality and are manufactured in compliance<br />
with GMP. In 2011 PQP prequalified its first APIs (six for antimalarials and two<br />
for antituberculosis medicines). Manufacturers are invited to apply on the basis<br />
of their products. The list of prequalified APIs is published on the <strong>WHO</strong> web<br />
site and a document confirming prequalification of the API is supplied to the<br />
manufacturer. NMRAs may also request further information on a particular API.<br />
As of October 2012, 62 applications for the prequalification of APIs had been<br />
received and 23 had been prequalified and published on the web site.<br />
The Expert Committee expressed appreciation for the report.<br />
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