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.

EXCiPACT asbl

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