The document – issued by audit body mdc medical device certification GmbH – indicates that excipient production, packaging and testing at the Sepiprod facility in Castres, France is conducted in compliance with standards set by Excipact.
The Excipact programme is a voluntary set of standards developed by the EFCG, IPEC Europe, IPEC Americas, FECC and PQG to give firms that audit excipient suppliers and distributors a framework for quality assessments in the absence of formal good manufacturing practices (GMP) requirements.
The idea is that this framework can be used by drug companies to prove to regulators that operations at their suppliers are up to a certain standards. Suppliers that become Excipact certified can present the document to their customers to reduce the number of site audits they must undergo.
Vive l’exipact
The Sepiprod site is the first excipient production facility outside Germany to be deemed to have met the required standards.
The firm – which as part of Seppic is a subsidiary of health industry gas, technology and services organisation Air Liquide – joins Aug. Hedinger, Merck KGaA and – recent addition – BASF on the list of suppliers that have achieved Excipact compliance.
Like the other firms that have made the grade, Sepiprod will undergo annual surveillance checks and a recertification audit every three years.
The news comes as IPEC Federation prepares to launch excipact as an independent scheme.
Speaking at CPhI last year European Fine Chemicals Group (EFCG) vice chairman Frithjof Holtz, head of advocacy at Merck Millipore said: “Excipact, up to now is a project under the legal roof of the IPEC Federation…but we intend to launch it as an independent, not-for-profit association in Brussels.”
He explained that the launch – which is expected to take place in weeks rather than months – will be accompanied by more training courses and efforts to recruit new third-party inspection organisations to join SGS and blue inspection body GmbH, which have both been approved to conduct excipact audits.