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EXCiPACT to Extend Postponement Interval for Audits

Changes to excipient manufacturer and distributor certification with regards to COVID-19 outbreak

24.03.2020 -

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 administration if a surveillance or re-certification audit is postponed and give an indication of the revised audit date.

EXCIPACT is working with Certification Bodies and its members to identify what steps could be taken to continue the Certification Scheme should the 6-month delay in scheduled audits be insufficient. Certification Bodies are also evaluating their options for ISO Certificate audits, including how modern technology can be used to conduct an audit with the auditor located off-site.

This is a rapidly evolving situation and EXCiPACT will update this position paper and republish it on the website as necessary.

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