Excipact – which was launched in January – is a certification scheme for people that inspect excipient suppliers and manufacturing facilities that is designed to let pharmaceutical excipient users focus their inspection activities more effectively.
The Excipact Association – which was set up by the IPEC Federation – told in-pharmatechnologist.com the training provided to SGS and blue inspection body auditors will give them the skills, knowledge of excipients, GMP, GDP and drugs to properly assess suppliers.
“Users of excipients which have been audited by Excipact registered auditors will then know that the auditor has been thoroughly trained in their needs and the needs of the regulators.
SGS and blue inspection body are the first services firms to have signed up to Excipact, but the Association said: “We are in discussion with other Certification Bodies. We will announce any agreements in due course.
Audit burden
The rationale behind Excipact is that a certification system ensuring the quality of audits will enable excipient users – including drugmakers – to comply with regulatory requirements in the most cost effective way possible.
“There is an expectation that all suppliers are physically audited,” the Association said, adding “this is impossible even given limited resources available to the excipient user because the suppliers could never host that many audits.”
To that end – under current regulatory guidance – it is recommended that drugmakers perform risk assessment to identify non-critical excipients, which is where Excipact comes in.
“The non-critical ones would not require them to perform the audit, but they could then rely on the Excipact scheme for that purpose. By having an Excipact Certificate and audit report available they can demonstrate compliance to the regulations and we then have a win-win situation.”
The approach – which sees compliant suppliers issued with an Excipact certificate for three years – is supported by both the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products regulatory agency (MHRA).