API monograph pilot gains momentum
Industry is increasingly developing products intended for submission worldwide, so the aim of having a single set of global specifications – as laid out by the International Conference on Harmonization (ICH Q6A) is desirable. The benefits include the avoidance of redundant testing by API suppliers and pharmaceutical manufacturers to meet differing international standards.
Susanne Keitel of the European Directorate on the Quality of Medicines gave an update on the pilot at a meeting of the European International Pharmaceutical Excipients Council (IPEC Europe) recently, noting that the project could make an important contribution to harmonisation efforts.
“A really beneficial impact of the pilot is that it helps to identify divergences in general methods that urgently need harmonisation,” Keitel told the meeting. Given the glacial pace of most pharmacopoeial harmonisation efforts that prioritisation process can only be a valuable exercise.
The hope is that the PDG – a forum for discussion between the pharmacopoeias in Europe, the US and Japan – will be able to publish the first harmonised monograph drafts in the second half of 2009.
The pilot is a bilateral exercise by the US Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur). The Japanese Pharmacopoeia has said it does not have the capability to contribute to the project right now, but might join in if the pilot phase is successful and resources become available.
So far the pilot is progressing nicely, said Keitel. However, she noted that a potential brake could be forthcoming when the PDG moves on to the thorny issue of reference standards – an area where there is still a fair amount of diverge between the USP and Ph. Eur.
