EXCiPACT Approves European Certification Body

Supported by extensive professional knowledge of blue inspection body GmbH, the mdc medical device certification GmbH represents the first European certification body for pharmaceutical excipients. mdc and EXCiPACT have signed a respective framework agreement. The EXCiPACT certification scheme is an initiative of industrial associations from excipient and pharmaceutical suppliers, aiming for a professional surveillance of GMP and GDP compliance. The initiative provides a certification scheme for regular monitoring of excipient suppliers by auditors from accredited certification bodies. The resulting EXCiPACT certificate and the respective audit report may be issued from the excipient supplier to their pharmaceutical customers. The first audits from mdc/blue are intended to be completed before the end of 2012.

According to Directive 2011/62/EC for pharmaceutical excipients such as Lactose, Cellulose or Glycerole, appropriate GMP shall be ascertained based upon a formalised risk assessment. Increasing regulatory GMP and GDP requirements for pharmaceutical excipients demand a tighter monitoring of the excipient supply chain by drug product manufacturers. Regular audits are therefore mandatory. Up to now, these GDP and GMP audits were coordinated by every drug product manufacturer individually. Manufacturers of certain excipients are facing more than 100 audits per year. It is the aim to pool and to improve these audits. For this purpose, EXCiPACT qualifies independent third-party auditors that are capable of auditing the companies according to pre-defined, fixed standards. Instead of conducting their own audit visits, drug product manufacturers will be able to refer to these audit reports and the EXCiPACT certificates.

“EXCiPACT has defined particularly high standards in order to ensure approval of these audit reports by the health authorities,” reported Dr. Stefan Kettelhoit of blue inspection body GmbH. “The manufacturing of excipients shall, for example, only be evaluated by auditors that belong to a certification body accredited by a national accreditation body such as the German Association for Accreditation in Germany.”

blue inspection body GmbH, +49 251 625620 40, stefan.kettelhoit@blue-inspection.com, www.blue-inspection.com.