Excipact Procedure For Audit Postponement And Remote Audits

6th April 2020

In response to the COVID-19 pandemic and following the EXCIPACT position paper of 24 March 2020, this document sets out a new procedure for audit postponement and the use of remote audits for those pharmaceutical excipients suppliers who are already EXCiPACT certified.

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.

The procedure is published as a Supplementary Annex to the “Additional Requirements for Certification Bodies and Auditors” in the 2017 version of the “EXCiPACT Certification Standards for Pharmaceutical Excipient Suppliers”.

You can download it here: 20200406 EXCiPACT Procedure for audit postponement and for remote audits