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ANSI certification expected soon

This article was originally published in The Gold Sheet

Executive Summary

Irwin Silverstein, vice-president and chief executive officer of International Pharmaceutical Excipients Auditing Inc., said that he expects the organization's third-party audit program of excipient suppliers to be certified by the American National Standards Institute by "the end of the first quarter of this year." He expects certification to ensure greater legitimacy - and acceptance - of IPEA's audit program among the pharmaceutical industry and FDA. He noted that "we're starting to gain more acceptance" with respect to third-party review of excipient suppliers. "2009 was a good year for the third-party certification program, it was a successful year." Silverstein further noted that "I think the agency sees the handwriting on the wall" with respect to third-party certification. "We think FDA will accept ANSI accreditation. The agency is one of the final arbiters. If ANSI says we have a good system, so should FDA." IPEA provides third-party audits of excipient manufacturers and auditor training and is an independent subsidiary of IPEC-Americas

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