Publications

Standards

The current standards are available either as a pocket-size booklet from info@excipact.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.

Policy Documents

Covid 19 Outbreak and EXCiPACT certification

EXCiPACT Position Papers on COVID-19

This document updates the position paper issued on 2nd March 2020.

Developments in the battle against COVID-19 have intensified rapidly. Recent epidemiological data has indicated the fight will last for some considerable time, especially in Europe. In light of this situation EXCiPACT has agreed to extend the postponement interval from 3 months to 6 months for a scheduled audit which is affected by the travel ban and other restrictions. This brings the EXCiPACT Certification Scheme fully into line with the IAF ID3 Guidance on dealing with extraordinary circumstances that may affect certification activities.

As mentioned in the original paper, if such exception is required, the Certification Body must inform EXCiPACT asbl administration (info@excipact.org) if a surveillance or re-certification audit is postponed and give an indication of the revised audit date.

EXCiPACT updated procedure for Audit Postponement and Remote Audits

In April 2020, in response to the COVID-19 pandemic, we issued a new procedure for audit postponement and the use of remote audits for those pharmaceutical excipients suppliers who are already EXCiPACT certified.

Effective December 2020, this procedure has been updated for the use of remote audits to replace on-site audits and included in version 2 of the SOP for this purpose available as a pdf on the opposite side of this Homepage.

Re-certification or surveillance audits may be impossible due to the strict travel ban and safety rules in place affecting both Certification Body auditors and staff from EXCiPACT-certified pharmaceutical excipient manufacturers and distributors. The procedure describes alternative options to help these suppliers to maintain or renew their EXCiPACT certification. It indicates the conditions and time-periods which are acceptable either to postpone a re-certification or surveillance audit or to replace it by a remote audit. EXCiPACT Registered Certification Bodies should prepare for its implementation in their internal procedures.

These requirements shall remain valid while the COVID-19 pandemic containment measures are in place in the affected world regions and until local regulation travel restrictions are suspended, and that physical (on-site) audits return to normal.

Articles

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

Other Publications

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