Consortium monitors the quality of excipients for medicinal products
New York (USA), Stuttgart (DE), Münster (DE), 15 September 2014. After the successful start in Europe, mdc medical device certification GmbH (mdc) now offers in cooperation with blue inspection body GmbH (blue) EXCiPACTTM audits for excipient manufacturers and distributors based in the USA and Canada. For these EXCiPACT™ audits, mdc/blue plan coordinated audit tours in North America, which will be conducted concurrently for several suppliers during one trip. Wolfgang Tessmer, Managing Director of the audit service provider blue (www.blue-inspection.com) explains: “Due to the bundling of several audits within one trip, the applicable travelling costs will be significantly reduced for each audited company”.
The EXCiPACT™ certification scheme represents an initiative of industrial associations from excipient and pharma suppliers aiming for an independent and impartial monitoring of Good Manufacturing Practice (GMP) compliance. The FDA accepts 3rd party audit certification schemes that meet certain criteria, as does the EXCiPACT™ scheme.
Certified monitoring instead of multiple independent audits
In the past, medicinal product manufacturers had to audit their excipient suppliers themselves. Major excipient manufacturers, which deliver their products to many pharmaceutical companies, are suffering from up to 100 audit requests per year by their customers.
Besides other things, it is the aim of the EXCiPACT™ initiative to bundle and standardize these inspections in order to decrease the number of audits. Rod Combs, an auditor employed by the certification body mdc (www.mdc-ce.de), states: “Due to the bundling of multiple independent audits by a single manufacturer based upon a detailed evaluation according to clearly defined, tough quality standards a valuable contribution for consistence on a high level is achieved. In addition, the management of audits by a truly independent third party increases acceptance by the user community“.
Instead of conducting their own audit visits, finished-dose drug manufacturers will be able to refer to audit reports provided by the supplier as well as the EXCiPACT™ certificates issued by mdc which will be visible on the EXCiPACT™ web site (www.excipact.org).
For excipient suppliers as well as pharmaceutical manufacturers the participation in the EXCiPACT scheme is on a voluntary basis. In order to benefit from the advantages of an audit tour in the USA and Canada, it is recommended by mdc/blue to raise requests early due to the typically high ongoing workload.
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