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.

References

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.

ots Originaltext: Excipact
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Dr. Hubertus Folttmann, +49-174-3198046 ,
hubertus.folttmann@basf.com