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 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.
How it works: An ISO 9001:2015 approved excipient supplier contracts with AJA Europe (EXCiPACT-approved independent third party Certification Body) agrees the audit scope and standard to be used (GDP,
GMP or both).
If the audit shows compliance, AJA Europe provides them with an EXCiPACT certificate and audit report to share with their customers (users).
Certification is valid for three years, includes annual surveillance audits, and as for all Certificate Holders, it is verifiable on the EXCiPACT website.