EXCiPACT Signs Agreements with Certification Bodies to Undertake Certified Audits of Pharmaceutical Excipient Suppliers

Brussels (ots/PRNewswire) - The EXCiPACT Association - a project of the IPEC Federation - is pleased to announce that it has completed Framework Agreements with two internationally-recognised Certification Bodies (CBs) for the certification of the manufacture and distribution of pharmaceutical excipients according to the EXCiPACT[TM] Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) Certification Standards. The CBs are mdc medical device certification GmbH / blue inspection body GmbH[1] and SGS[2].

Auditors employed by these organisations who have completed the formal EXCiPACT Training Programme will now undertake EXCiPACT-witnessed pilot audits of pharmaceutical excipient suppliers. The independent witnesses will allow EXCiPACT to verify that the standards and the auditor training have been defined and implemented correctly. Once each auditor has been assessed satisfactorily then they will become a fully qualified Certified Auditor under the EXCiPACT[TM] Certification Scheme.

The EXCiPACT Scheme has been made available at a time when the regulators in the EU and USA require the holder of the marketing authorization for medicines to ensure that appropriate GMP and GDP is applied to the manufacture and distribution of both APIs and excipients. The requirement for site audit by FDA and EMA continues to be pressed for pharmaceutical excipients and as a result their suppliers must be prepared to receive increasing numbers of audits. EXCiPACT Certification can help to avoid some of these additional audits in a cost-effective manner. EXCiPACT expects to register other Certifying Bodies and Auditors in the near future.

Notes for the Editor

EXCiPACT is a project of the IPEC Federation, a global organization to promote quality in pharmaceutical excipients. (see http://www.ipecfed.org ). EXCiPACT is a voluntary international scheme to provide for independent 3rd party certification of manufacturers, suppliers and distributors of pharmaceutical excipients worldwide. It will ensure patient safety through supplier quality while minimising the overall costs for assessing the excipient supply chain. It was launched in January 2012 since when there has been considerable interest among pharmaceutical excipient suppliers, customers and regulators. For further information see http://www.excipact.org or contact info@excipact.org.


1 & 2: For further information about mdc medical device certification GmbH /blue inspection body GmbH and SGS see http://www.mdc-ce.de/index_en.htm , http://www.blue-inspection.com and http://www.sgs.com respectively.


Dr. Hubertus Folttmann, +49-174-3198046 ,

Das könnte Sie auch interessieren: