EXCiPACT (Pharmaceutical Excipient) Certification
The EXCiPACT certification is a voluntary and ISO-based international certification program designed for pharmaceutical excipient manufacturers, suppliers, and distributors worldwide and accepted by main pharmaceutical manufacturers and regulators.
What is EXCiPACT?
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.
What are Pharmaceutical Excipients?
Pharmaceutical excipients are substances other than the Active Pharmaceutical Ingredient (API) that have been appropriately evaluated for safety and are intentionally included in a drug delivery system.
Benefits of EXCiPACT Certification
- Improve quality and safety of pharmaceuticals
- Improve safety of supply chain by conducting annual audit
- Reduce the cost of audit of supplier and client
- Obtain confidence from the certificate issued by accredited CB
- Meet the requirement of risk assessment
- Minimize potential problems in the manufacturing, distribution and warehousing
- Help to find qualified supplier
How to get an EXCiPACT Certificate
Cotecna can provide an accredited certification against the EXCiPACT standard. Clients and customers willing to undergo certification needs to complete the application and contract agreement process following which initial or re-certification audits will be carried out. Once the certificate is issued (with a 3 year validity), further surveillance audits will have to be carried out at pre-defined frequencies to maintain the validity of the certificate.
Kaixin Certification, member of the Cotecna Group, is an EXCiPACT approved certification body that is authorized to perform an EXCiPACT audit.
Request a Certification
To request an audit, or for more information on the certification process, please don’t hesitate to contact us.