Gelatin firm Rousselot BV has joined IPEC Europe describing the move as an opportunity to contribute to the development of regulatory standards for pharmaceutical excipients.
IPEC Europe has reminded drugmakers they have less than a year to risk assess all excipients used in their products under recently introduced EU rules.
Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.
US pharmaceutical firms ‘fear change’ and need guidance on assessing safe excipient supply to become more like their European counterparts, says a senior IPEC expert.
The International Pharmaceutical Excipients Council (IPEC) of Europe has outlined the actions it is taking as it continues to develop awareness of the need for safe excipients.
