Excipient cGMP Certification Organisations
Regulators require excipient users to qualify their suppliers based on GMP/GDP audits and they have indicated that third party auditing of suppliers is acceptable if a creditable certification body issues certificates and audit reports by employing qualified auditors who are demonstrably credible in suitable GMP/GDP standards and in the needs of the pharmaceutical industry. EXCiPACT asbl is a non-profit organisation that owns and manages oversight of such an independent, high quality, third party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.
Click here to read more about EXCiPACT.
NSF Health Sciences Certification, LLC
NSF Health Sciences Certification, LLC (a wholly-owned subsidiary of NSF International) offers the U.S. market the only excipient Good Manufacturing Practice (GMP) certification program accredited by the American National Standards Institute (ANSI). Third-party certification audits are based on our NSF/ANSI certification program.
NSF’s expertise in helping to facilitate standards development and certification helps excipient manufacturers demonstrate a high level of GMP compliance against the NSF/IPEC/ANSI 363 GMP standard. This consensus standard was developed with the involvement of excipient manufacturers, excipient customers and the U.S. Food and Drug Administration. NSF/IPEC/ANSI 363 was first issued in 2014 and follows the ISO 9001 framework. Copies can be obtained for purchase at https://webstore.ansi.org/standards/nsf/nsfipecansi3632016 by emailing [email protected].
NSF certification to the NSF/IPEC/ANSI 363 standard can be accomplished in approximately three months depending on the level of preparedness of the excipient manufacturer. To determine your company’s readiness for certification it is best to complete an internal assessment against the NSF/IPEC/ANSI 363 GMP standard or engage a third party to conduct this assessment. NSF can perform this preliminary assessment; however, this is an activity managed separately from the excipient certification program. Please contact [email protected] if you are interested in a preliminary assessment or if your company is interested in certification to the NSF/IPEC/ ANSI 363 GMP Standard.
To get answers to the most common questions about certification check our FAQ.
Upon GMP certification a Certificate of GMP Conformance is issued to the excipient manufacturer. Audit reports are made available to excipient customers either from the excipient manufacturer directly or NSF can provide authenticated reports with the excipient manufacturer’s authorization.
Confidentiality and absence of bias is rigorously managed through NSF procedure and NSF Corporate Quality oversight.
Click here to get more information on NSF.