IBFGROUP

Regulators require excipient users to qualify their suppliers based on GMP/GDP/GWP 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/GWP standards and in the needs of the pharmaceutical industry. EXCIPACT is a non-profit organization that owns and manages oversight of such an independent, high-quality, third-party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.