IPEC says supplier qualification way to go in resolving poor quality talc in South Korea
This article was originally published in The Gold Sheet
Executive Summary
The International Pharmaceutical Excipients Council contends that implementing new drug master file regulations for talc is not the best solution for resolving the issue of poor quality talc found in certain drug and cosmetic products in South Korea. A recent incident involving asbestos-tainted talc in these products prompted the Korean Food and Drug Administration (KFDA) to draft proposed DMF requirements for talc (see 1"The Gold Sheet," May 2009). In response to this action, IPEC-Americas and IPEC Europe jointly developed formal comments to Nam-su Kim in the pharmaceutical safety bureau of KFDA objecting to these new DMF requirements. The letter, signed by Janeen Skutnik, chair of IPEC-Americas, states that implementation of a DMF system as proposed will not resolve compliance-based issues. "IPEC believes that the use of modern compendial testing and good supplier qualification practices on the part of the user of the talc provides appropriate control of talc quality as it relates to asbestos contamination and that the proposed talc DMF requirements may lead to an unnecessary increased burden on excipient manufacturers and users without actually improving quality or safety to patients.