Supplier qualification is "more than auditing"
The current EU rules for supplier qualification are "wide-ranging and complex" and more than auditing is required to be confident that suppliers, vendors and contractors are able to supply materials, components and services of consistent quality and in compliance with the regulations.
That's the verdict of a recent ECA article, which lists the relevant EU directives and regulations and describes a process that includes identifying and specifying the regulatory requirements for the material, auditing (if required) to show compliance and – after a contract is signed – periodic evaluations of compliance and monitoring any pertinent changes at the supplier's site.
"Excipient suppliers should be aware of the requirements detailed in this article," according to IPEC Europe senior advisor Adrian Bone. "While of course they are only applicable to pharmaceutical manufacturers, IPEC guidance documents have been developed with due reference to these 'user requirements' to establish common expectations for excipients (as starting materials) facilitating regulatory compliance across the excipient supply chain."
It is also important for excipient manufacturers to be properly aware of the requirements placed upon their users so that they themselves can enter into a good dialogue with their customers, he said. This should help to ensure that relative roles and responsibilities and well understood, to deliver, for example, meaningful quality agreements.
"Attaining this 'level playing' field of understanding also helps customers develop higher quality 'Formalised Risk Assessments of Excipients', a very important new requirement," concluded Bone.