API monograph pilot gains momentum

By Phil Taylor, 25-Feb-2009

Related topics: Globalisation, Materials & Formulation, Ingredients, excipients and raw materials

An active pharmaceutical ingredient (API) pilot project, implemented by the Pharmacopoeial Discussion Group (PDG) last summer and aimed at harmonising API monographs, should generate its first results before the end of the year.

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.

ver mas