The International Pharmaceutical Excipients Council (IPEC) of the Americas is working on a new set of guidelines for pharmaceutical excipients qualification, which will help the global pharmaceutical companies to ensure the quality of excipients used in their products.

The move comes relevant as the drug regulators in US and China have identified several adverse reactions during the last two years wherein the non active pharmaceutical ingredients played a major role. The new work on excipients qualification will act as the umbrella guideline of all the guidelines prepared by the IPEC for keeping up the excipients quality, according to David R Schoneker, chairman, IPEC of the Americas.

"The new guideline will have specifications on how to use the other guidelines so that we have to fully qualify the quality supply of excipients. The norms are prepared by looking the issues both from the standpoint of excipients suppliers who are catering to the pharmaceutical sector and the industry which relies on the quality of excipients used in their products," said Schoneker, who is also working with Colorcon Inc as the director of Global Regulatory Affairs.

In the last two years, regulators like US Food and Drug Administration (FDA) have identified issues related to excipients in pet food where Wheat Gluten contaminated with Melamine, tooth paste contaminated with DEG from Glycerine and finally the Heparin contaminated with similar but different material which is still being investigated. Though there is no connection with excipients in heparin, the IPEC was consulted by the US FDA as it has some supply chain management issues.

With these instances, the regulators like US FDA and the China State Food and Drug Administration (SFDA) have realised the need for a lot more care on excipients and they are raising more queries on ways to assure quality of excipients, which is currently supplied to the industry from various parts of the world.

IPEC Americas has been developing guidelines for excipients manufacturing and distribution along with implementing certification programmes for audits and analysis for last fifteen years, to fill the gap in the regulatory aspects of excipients in various countries. The IPEC is working closely with the US FDA to bring in a new legislation on the excipients qualification, in the backdrop of the recent events, he added.

The legislation will address the issues of auditing each excipient suppliers of the pharmaceutical industry in the country. Currently, though many of the companies conduct auditing their major suppliers, a majority of the suppliers remains unaudited, as they are huge in numbers and not even recognised as the excipients suppliers. IPEC is also conducting third party auditing for the pharmaceutical industry and comes up regularly with audit reports which could be bought by the industry in cheap rates, said Schoneker. IPEC's GMP for excipients has already been included in the General Chapter of US Pharmacopoeia.

The IPEC's guidelines will get more importance globally, as the Council has decided to set up its operations in the emerging pharmaceutical markets, including India, China and Brazil, soon. "We will introduce the guidelines, already prepared, and the new ones in these countries once we set up the operations there. We are looking up for harmonisation of the guidelines, which are already followed by many of the industry players in US, Europe and Japan," he added.