Certification program for pharmacutical excipients nears reality

13 October 2009 22:42  [Source: ICIS news]

MADRID (ICIS news)--The key components are in place for the excipient industry to introduce a certification program, a board member of the European Fine Chemical Group (EFCG) said Tuesday in Madrid.

Speaking at CPhI Worldwide, the annual exhibition for the pharmaceutical supply chain, Arnulf Heubner said that the EFCG and its partners have made considerable progress in developing a voluntary certification program to protect the quality of pharmaceutical excipients, inactive ingredients comprising on average about 90% of drug products. The EFCG's partners are IPEC Europe (International Pharmaceutical Excipients Council), IPEC-Americas, the Pharmaceutical Quality Group and European chemical distributors organization FECC.

The program includes a classification scheme based on risk; GMPs (good manufacturing practices) and GDPs (good distribution practices); third-party audits; and a certification scheme. Heubner estimated that the entire package would be ready in 2010, at which point the group would negotiate the process with regulatory authorities.

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By: Clay Boswell
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