Once again, our factory have been audited this year by EXCIPACT and our certification have been renewed for 3 years for the second time.
What Is EXCiPACT?
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.
Certification is valid for three years, includes annual surveillance audits, and as for all Certificate Holders, it is verifiable on the EXCiPACT website.
In the EU and USA all manufacturing authorization holders for medicines must ensure that appropriate GMP/GDP is applied to the manufacture and distribution of pharmaceutical excipients. Regulators there agree that certification schemes built on the principles of oversight applied by EXCiPACT asbl ensure quality, safety and help reduce the audit burden for both suppliers and users.
EXCiPACT is a registered trademark.