The team behind the scheme that helped BASF, Seppic and Merck KGaA reduce their audit burdens expect more excipient suppliers to seek certification as an independent association.
The Excipact scheme – a certification programme for third-party auditor and excipient suppliers – left industry group IPEC Federation and established itself as a Brussels, Belgium-based independent organisation at the end of January.
Tony Scott, a consultant who advises the Excipact team, told in-Pharmatechnologist.com that: “The five founding members of EXCiPACT asbl - EFCG, FECC, IPEC-Americas, IPEC Europe and PQG - are all independent associations in their own right and for some setting up and operating a Certification Scheme was not compatible with their purpose.
“In addition, by establishing a separate legal entity, all are released from any further financial obligations.”
The other advantage independence Excipact gives is that it “greatly simplifies the signing of any contracts and related legal obligations,” according to Scott.
The new alliance will be funded through fees paid by manufacturers and auditors that use the scheme as well as training schemes for auditors, Scott said, however, this does represent a significant change to the organisation’s operations.
“In effect there will be no change here as the registration as a not-for-profit organisation has not changed any of the interactions we have with our immediate stakeholders.
“The establishment of EXCiPACT asbl now allows the Association to fully market and implement the Certification Scheme globally. As such, we expect the next period to be very busy in that respect.”