EXCiPACT Certification Body Registration Requirements

If you are interested becoming a registered EXCiPACT Certifying Body please note the following summary of requirements:

  • Have a legal agreement with EXCiPACT asbl to offer their certification scheme to suppliers;
  • Have been audited by EXCiPACT asbl auditors to ensure their rules are applied pre-certification and then every 3 years;
  • Only use EXCiPACT registered auditors to audit against the EXCiPACT GMP and GDP Standards or the NSF/IPEC/ANSI 363-2014 GMP US National Standard;
  • To apply the requirements in ISO 17021 (Conformity assessment requirements for bodies providing audit and certification of management systems) – or equivalent standard, and the EXCiPACT Annex to ISO 17021 to the auditing and certification of excipient suppliers;
  • Act with impartiality and have no conflicts of interest in their auditing of excipient suppliers (i.e. not having provided consultancy or otherwise worked for the supplier in the past 2 years);
  • Have an independent certification board that decides on certification – not the Auditor; and
  • Have been periodically audited by EXCiPACT to verify these arrangements are in place.