Benefits of IPEA Certification program to industry
IPEA has been auditing excipient suppliers since 2001 and has been accredited by ANSI since 2010. The excipient and pharmaceutical industry can now benefit from the IPEA certification program through assurance of the conformance of excipient suppliers to GMP requirements without the need for a site audit. The benefit to the excipient supplier is a reduction in their resources to host frequent customer audits and assurance that the excipient GMP audit is conducted against appropriate GMP conformance expectations. The supplier also has an opportunity to review the certification audit report to assure the accuracy of observations and can provide a corrective action plan if warranted.
The pharmaceutical customer benefits from assuring excipient-supplier GMP conformance without the expense of a site audit. More importantly, the assessment by the IPEA certification auditors, which is more extensive than excipient manufacturers typically allow for a pharmaceutical audit, results in additional confidence in the appropriateness of the excipient GMP quality system. IPEA's annual surveillance audit and biannual recertification assure the excipient site maintains their conformance to GMP. The pharmaceutical user also has an opportunity to review the Certification Audit Report at nominal cost for confirmation of substantial conformance to excipient GMP with approximately 80% of the proceeds used to defray the certification maintenance costs.
IPEA is represented on the committee that is currently developing an ANSI standard for excipient GMP. NSF, an ANSI standards development body, has organized a committee of experts for this purpose in accordance with ANSI procedures. IPEA will certify conformance to the ANSI excipient GMP standard upon its adoption.