The current standards are available as a pocket-size booklet from email@example.com, please request via our contact form for the standards entitled “EXCiPACT - Certification Standards for Pharmaceutical Excipient Suppliers: Good Manufacturing Practices, Good Distribution Practices, Good Warehousing Practices – Requirements for Auditor Competency and Third Party Audit Organisations Providing Certification of the Management System”, version 3, 2021.
The 2021 version with the inclusion of the new GWP certification standards updates the 2017 version.
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 (firstname.lastname@example.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 (SOP-QM-001) for audit postponement and the use of remote audits for those pharmaceutical excipients suppliers who are already EXCiPACT certified. This procedure has been updated annually since to reflect changes in COVID-19 restrictions.
The success of remote audits during the COVID-19 lockdowns indicates remote audits have a place if risks are identified and managed. Accordingly, we have made some changes to SOP-QM-001, and subject to certain conditions Stage 1 audits can be conducted remotely. This should be recorded in the form of a documented risk assessment considering for example, site history, product range and be acceptable to the supplier.
While on-site (S1) audits are preferred but not always possible, a remote S1 audit, for example, some time before the actual S2 audit is preferred to performing S1 on one day and commencing S2 on the next day.
Specific criteria are:
- The risk assessment concludes the any identified risks can be managed such that the S2 audit quality is not compromised. (A noticeably lower GMP standard during the S2 audit than was observed in the S1 video tour would be a Major non-conformity).
- The Certification Body/Auditor and client must agree to the arrangement.
- A ‘live’ video tour of the manufacturing facility must be available.
- The content and duration of the remote S1 audit is the same as an on-site audit.
- The updated process included in version 4 of the SOP is available as a pdf on this this Homepage
Manufacturingchemist.com, May 2021, Remote audits are on the increase, but more must be done to develop novel excipients, Dr Iain Moore, EXCiPACT President
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, 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