Aiming for tighter surveillance of excipients used in medicines

Baltimore (USA), Münster (DE), 06 May 2013. The EXCiPACT certification scheme, an initiative of industrial associations from excipient and pharma suppliers, has officially been launched in the US. EXCiPACT is aiming for an independent and impartial monitoring of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance. The manufacturing and distribution operations of excipient suppliers will be subject to regular on-site monitoring by auditors from accredited Certification Bodies. A few weeks ago, EXCiPACT has accredited mdc medical device certification GmbH in cooperation with blue inspection body GmbH as the first global Certification Body. „We have already conducted several pilot audits in Germany“, states Dr. Stefan Kettelhoit, Managing Director of blue inspection body, at the launch meeting of EXCiPACT during the Expo & Conference ExcipientFest in Baltimore: „The new surveillance system for excipients is operational.“

Single Audits to be replaced by certified audit reports

Currently, each finished-dose drug manufacturer coordinates his own on-site audits in order to monitor GMP and GDP compliance of excipients such as Lactose, Cellulose or Glycerole individually. Some manufacturers of excipients face more than 100 audit requests of different customers per year. It is the aim of the EXCiPACT initiative to pool, to improve and to standardize these audits. „The slogan is ‚Less but more professional audits’, EXCiPACT has thus defined particular high standards for every single audit“, explains Dr. Stefan Kettelhoit from blue inspection body GmbH ( „It is thereby ensured, that these kind of new excipient Third-Party-Audits are also accepted by the health authorities globally.“ Instead of conducting their own audit visits, finished-dose drug manufacturers will be able to refer to these audit reports and the EXCiPACT certificates. For excipient suppliers as well as pharmaceutical manufacturers the participation at the EXCiPACT scheme is on a voluntary basis.

The Expo & Conference ExcipientFest took place from April 29th to May 3rd in Baltimore, Maryland (USA).

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