Hedinger participated in February 2013 as the first excipient supplier in the pilot phase of the EXCiPACTTM certification scheme providing third party certification of GMP and GDP compliance. GMP and GDP certificates for Hedinger have been granted by mdc on June 25th, 2013. mdc (medical device certification GmbH, Stuttgart, Germany) is the first approved EXCiPACTTM certification body. Our EXCiPACTTM GMP and GDP certificates in conjunction with the detailed audit report of the independent auditor of mdc provide evidence of our high level of GMP and GDP compliance according to the global EXCiPACTTM standard.
EXCiPACTTM is a global third party certification system providing verification and certification of GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) compliance of manufacturers and distributors of pharmaceutical excipients. This system contributes to excipient safety, transparency of excipient supply chain and provides independent information about GMP/GDP compliance of excipient suppliers which may be used by pharmaceutical companies to reduce their own audit burden of certified suppliers.
The EXCiPACTTM standard is aligned to the ISO 9001 quality system certification. Therefore, an EXCiPACTTM certificate is only valid in conjunction with an ISO 9001 quality system certification. EXCiPACTTM certification audits are carried out every 3 year at the supplier sites, surveillance audits in the years between ensure the maintenance of the quality system standard between the certification audits.
Site Stuttgart:
Download EXCiPACT-Certificate
Site Teutschenthal:
Download EXCiPACT-Certificate
