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Impact of COVID-19 outbreak on the EDQM Certificate of Suitability (CEP) procedure

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Certification of suitability (CEP)
News
13 March 2020
Strasbourg, France

The EDQM would like to inform CEP holders of the impact of the COVID-19 outbreak on activities related to the CEP procedure.

With regards to sending CEPs, due to issues experienced in shipping/delivering CEPs in some zones considered at risk, the EDQM is contacting the relevant CEP holders in advance to confirm that delivery is possible or to propose alternatives when companies are closed.

EDQM is aware that companies may have issues regarding submissions of information linked to CEP dossiers under assessment (e.g. preparing and sending responses to deficiency letters), inspections (e.g. preparing and sending CAPA) and risk assessments related to nitrosamines. However, EDQM expects to be informed as soon as possible by CEP holders/substance manufacturers if they cannot meet the deadline for submitting the requested information.

To anticipate any further disruption of availability of material, companies are also advised to inform their customers well in advance of any changes they intend to make and of any revision they intend to submit.

EDQM has also taken the decision to postpone inspections of API manufacturers due to current travel restrictions, and will inform individually the companies concerned.

EDQM is currently reviewing the impact of this issue on assessment activities and timelines, and will do everything possible to mitigate the impact and will communicate any new action that will be put in place.

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