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Drug Safety Of Excipients

June 20, 2011 | A version of this story appeared in Volume 89, Issue 25

■ June 6, page 5: The bill to ban nontherapeutic use of medically important antibiotics in farm animals is H.R. 965 in the 112th Congress.

I was pleased to see the article “Shock to the System” in which the issue of drug safety and supply-chain security was discussed (C&EN, May 16, page 11). For the sake of completeness, I think it is important to make readers aware of another audit-sharing organization, International Pharmaceutical Excipients Auditing Inc. (IPEA).

IPEA was organized by the International Pharmaceutical Excipients Council of the Americas (IPEC) in 2001 with the purpose of sharing audit reports of excipient manufacturers. The objective is to lower the cost for the assessment of excipients and thus increase assurance that these ingredient suppliers are audited. Unfortunately, this program has been slow to gain traction with the industry.

During a review of the program with the Food & Drug Administration in 2008, it was suggested that IPEA become accredited by the American National Standards Institute (ANSI) to issue certification of excipients to Good Manufacturing Practices (GMP). IPEA was accredited by ANSI in April 2010 and has issued certification to a manufacturer of Propylene Glycol USP and of Silica Gel NF at two manufacturing sites each. The certification program is gaining recognition with FDA and with this industry.

By Irwin Silverstein
Arlington, Va


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