The current standards are available either as a pocket-size booklet from firstname.lastname@example.org, our contact form or download standards here entitled “EXCiPACT - Certification Standards for Pharmaceutical Excipient Suppliers: Good Manufacturing Practices, Good Distribution Practices – Requirements for Auditor Competency and Third Party Audit Organisations Providing Certification of the Management System 2017”.
Download here the Chinese version of the standards.
The 2017 version updates the original 2012 version following alignment to the ISO 9001:2015 and ISO/IEC 17021-1:2015 Standards. To view the 2012 version please click here.
Industrial Pharmacy, Issue 57, April 2018, Pharmaceutical excipient regulations: how the EXCiPACT certification scheme can reduce the audit burden for both suppliers and users, Tony Scott, Senior Adviser, EXCiPACT
Chemmanager-online.com, October 2017, The EXCiPACT Certification Scheme, Tony Scott, Senior Adviser, EXCiPACT
EPM Magazine September CPhI Issue 2016, ‘Pure Potential’ page 27 by Kevin McGlue, EXCiPACT President
EXCiPACT: Taking an idea to global reality. Introduction to EXCiPACT organisation and scheme, Kevin McGlue, EXCiPACT Certification Workshop, Mumbai, 29 November 2018
European Regulations for Excipients & the application of EXCiPACT, Kevin McGlue, EXCiPACT Certification Workshop, Mumbai, 29 November 2018