Regulatory pressure for risk-based supply chain management is increasing excipient suppliers’ audit burden according to the team preparing to launch the 'excipact' certification scheme as an independent association.
The comments came from European Fine Chemicals Group (EFCG) vice chairman Frithjof Holtz, head of advocacy at Merck Millipore, who told attendees at CPhI in Frankfurt, Germany last week the economic burden extra audits places on suppliers and excipient users “should not be underestimated.”
“There are increasing expectations from regulators on ensuring the safety of the supply chain means more physical audits of manufacturers, suppliers and also distributors, warehouses, forwarders and so on.”
He cited –in Europe - the FMD which requires risk assessment for appropriate good manufacturing practices for excipients and moves to revise GMPs and – in the US – FDASIA’s supplier registration requirement as examples of regulatory moves that have increased the audit burden.
The excipact certification scheme – which was developed by IPEC, EFCG, FECC and PQG – may be a solution for suppliers and users looking to minimise this economic impact according to Holtz.
“One way of handling the challenges of quality standards for excipients and of physical audits might be excipact” he said, adding that this would also fit with growing regulatory support around the world for the use of third party auditing schemes.
The excipact scheme is designed to provide excipient users with the assurance that the people who assess their suppliers are working to appropriate standards and let suppliers minimise the number customer audits they undergo each year.
“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.
“We started in Europe in 2012 and held the launch even in April in the US,” Holtz said adding that as the drug excipients industry is global a potential roll out of the scheme in Asia is a possibility, although as yet nothing has been scheduled.