UPDATED: Excipient makers jump on audits as new regs kick in

The FDA and other regulators have made it clear they want drugmakers to audit their suppliers to make sure ingredients are safe and sound. The International Pharmaceutical Excipients Council (IPEC) in Europe spun off its excipient certification operation Jan. 29 into EXCiPACT, an independent operation, and already it has announced a handful of certifications of companies around the world as suppliers scramble to meet the new expectations.

When the group became independent, the new board chairman, Iain Moore, explained that "This scheme can help all parties meet their legal obligations and at the same time to reduce their audit burden, save costs and ensure quality." Last year the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) sold its IPEA auditing subsidiary to NSF International.

In the last few days A&C American Chemicals in Canada, Sonneborn Refined Products in the Netherlands, Biogrund in Germany and Saudi Kayan Petrochemical in Saudi Arabia have all been certified.

Manufacturing Chemist points out that the FDA and European excipient regulations now require drugmakers to either perform audits themselves on all of their supplies or have it done by an acceptable group to prove their materials meet manufacturing and distribution standards.

The need for supply audits became clear in the U.S. in 2008 when the FDA started getting reports that patients on dialysis taking heparin were having severe hypersensitivity reactions. The agency said 10 other countries were also reporting problems. The FDA tracked the problem back to crude heparin which contained oversulfated chondroitin sulfate (OSCS) that had come from China, the largest supplier to heparin manufacturers. The agency found that Chinese suppliers intentionally used oversulfated chondroitin sulfate because it was cheaper.

Since then the FDA has banned supplies from 22 Chinese companies and required heparinmakers to test all heparin for OSCS as well as for nonporcine ruminant material contaminants and audit their suppliers regularly.

- here's the announcement (PDF)
- get more on new certifications

Editor's Note: The story has been update to reflect that EXCiPACT is a EU organization while the auditing operation of IPED Americas was sold last year to NSF International.