Excipients Certification Ensures Quality of Supply Chain

The EXCiPACT Association — an initiative of the IPEC Federation — will be exhibiting for the first time at CPhI. EXCiPACT is a new, voluntary international certification scheme, providing independent third party certification of worldwide pharmaceutical excipient suppliers.

Recently, two German suppliers — Aug. Hedinger GmbH & Co.KG and Merck KGaA — received the first EXCiPACT certificates issued by mdc medical device certification GmbH, one of EXCiPACT’s internationally-recognised independent third party certification bodies.

EXCiPACT Certification demonstrates that these organisations manufacture and distribute pharmaceutical excipients according to the EXCiPACT GMP and/or GDP certification standards.

Both mdc and its auditors underwent a rigorous assessment process in order to become EXCiPACT registered. Their auditors completed the formal EXCiPACT Training Programme and were independently witnessed to verify that they met the required, high-level competency standards.

The EXCiPACT Certification Scheme has been made available at a time when the regulators in the EU and US require the holder of the marketing authorisation holders (MAHs) for medicinal products to ensure that appropriate GMP and GDP is applied to the manufacture and distribution of excipients.

Visitors are invited to learn more about the scheme and how EXCiPACT can help to minimise their audit burden, save costs and maximise benefits in the face of increasing pressure from regulators to improve the quality of the excipient supply chain.

Stand 62F61

EXCiPACT Association, info@excipact.org, www.excipact.org.