The first Certification Body for ‚Excipients’ starts to work

Muenster, 28 November 2012. 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 pharma suppliers, aiming for a professional surveillance of Good Manufacturing Practice (GMP) and Good Distribution Practice (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.

Certified audit reports instead of a multitude of single audits

According to Directive 2011/62/EC for pharmaceutical excipients such as Lactose, Cellulose or Glycerole, appropriate GMP shall be ascertained based upon a formalized 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. Manudfacturers 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, who 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“, reports 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 GmbH, DAkkS in Germany.“ As the first certification body ever fulfilling these requirements, mdc/blue inspection was approved by EXCiPACT.

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