EXCiPACT PROCEDURE FOR AUDIT POSTPONEMENT AND REMOTE AUDITS
In response to the COVID-19 pandemic and following our 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”.
THE COVID-19 OUTBREAK and EXCiPACT Certification
Updated Position paper 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.
What Is EXCiPACT?
Regulators require excipient users to qualify their suppliers based on GMP/GDP audits and they have indicated that third party auditing of suppliers is acceptable if a creditable certification body issues certificates and audit reports by employing qualified auditors who are demonstrably credible in suitable GMP/GDP standards and in the needs of the pharmaceutical industry. EXCiPACT asbl is a non-profit organisation that owns and manages oversight of such an independent, high quality, third party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.
Who Is Certified
Click here for the list of our certificate holders who currently are based in 15 countries. 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. Our certificate holders and their customers are increasingly enjoying the benefits of EXCiPACT certification. Consistent annual growth is being achieved by our Registered Certification Bodies.
How It Works
An ISO 9001:2015-approved excipient supplier contracts with an EXCiPACT-approved independent third party Certification Body, agrees the audit scope and standard to be used (GDP, GMP or both), and, if the audit shows compliance, the Certification Body provides them with an EXCiPACT certificate and audit report to share with their customers (users). Certification is valid for three years, includes annual surveillance audits, and as for all Certificate Holders, it is verifiable on the EXCiPACT website.
SUPPLIER COSTS - 3yrs Audit, certificate, surveillance
SUPPLIER SAVINGS - 3yrs Less customer audits, travel, admin
PHARMA COMPANY SAVINGS - 3yrs Less supplier audits, travel, admin
- Saves both supplier and their customers money
- Provided by approved third party Certification Bodies
- Reduces audit burden and cost for supplier and user
- Supported by key regulatory bodies
- Helps excipient users identify qualified suppliers
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