The Board of EXCiPACT asbl is pleased to announce the publication of their 2017 Certification Standards for Pharmaceutical Excipient Suppliers on their new website www.excipact.org. These Standards are the key components of the EXCiPACT Certification Scheme which comprises:
1. The EXCiPACT GMP standard for excipients as an annex to ISO 9001:2015
2. The EXCiPACT GDP standard for excipients as an annex to ISO 9001:2015
3. Certifying Body competency qualification as an annex to ISO/IEC 17021-1:2015
4. Auditor competency qualification as an annex to ISO/IEC 17021-1:2015.
Developed by pharmaceutical excipient suppliers and users, the Scheme’s core objectives are to demonstrate a safe, reliable, transparent pharmaceutical supply chain, and to reduce the audit burden, costs and resources for manufacturers, distributors and users of pharmaceutical excipients without compromising quality. The 2017 Standards reflect the changes in the ISO 9001:2015 and ISO/IEC 17021-1:2015 Standards.
Presently there are over 60 certificate holders based in 15 countries listed on the website. They range from major international suppliers with multiple sites, to single site, smaller suppliers in Asia, Europe, Mid-East and N. America. This list is a reliable source regularly used by pharmaceutical companies during their supplier qualification process and to access audit reports and certificates.
A pocket-sized, hard copy of the 2017 Standards will soon be available at no cost from info@excipact.org similar to that for the original 2012 Standards.