The Netherlands-headquartered announced its membership of the International Pharmaceutical Excipient Council (IPEC) Europe last week, claiming it is the first gelatin manufacturer to join the industry group.
Membership will provide Rousselot with the opportunity to contribute to the development of future quality guidelines and regulatory standards according to Joel D’Silva, director of the firm’s global regulatory affairs unit.
He told us “We first aim to participate in IPEC Europe committee work to be updated on new developments in excipient quality standards and regulations.
“Second, we see an opportunity to contribute to future updates of guidance on GMP, auditing and excipient risk assessment criteria” D’Silva continued.
Around 92% of the hard capsules and 77% of the softgels used by the drug industry are made with gelatin according to D’Silva, who said “we also thought that we could positively contribute to IPEC in bringing our expertise and knowledge about gelatin.”