abpi News
One of the great pharmaceutical imponderables over the years has been the degree to which excipients should be the subject of Good Manufacturing Practice (GMP). While everyone seems to concur that it would be a 'good thing', there has never been universal agreement as to at what level, or how, any such standards should apply.
Indeed, in its proposals for reviewing medicines legislation, the European Commission seems, for the time being at least, to have ducked the question by insisting on GMP compliance only for active pharmaceutical ingredients.
There are now a number of 'GMP guides' for excipients, either published or in draft form. The International Pharmaceutical Excipients Council (IPEC) has had such a guide for some years, and more recently the UK's Pharmaceutical Quality Group has issued a draft proposal for such a guide. Also a World Health Organisation guideline has been published on this subject.
Understandably, pharmaceutical manufacturers and their suppliers are confused. In the age of increasing global harmonisation, and given the very successful development of its guideline Q7A on Active Pharmaceutical Ingredients, there is a strong case for development of an International Conference on Harmonisation (ICH) guideline on this topic.
A lack of such harmonisation can only result in a proliferation of guidelines with differing approaches and sometimes contradictory requirements, which will present a regulatory quandary for manufacturers, suppliers and regulators alike as they have to decide which guide really does represent current GMP for excipients.