GCP Inspections 'Indispensable' During Pandemic

EMA Explains Approach To Remote GCP Inspections During Coronavirus Pandemic

The European Medicines Agency says good clinical practice inspections are indispensable even in the midst of a pandemic. It has set out requirements and specificities of undertaking inspections remotely where feasible. 

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Preparations For Remote GCP Inspections Can Be More Demanding • Source: Shutterstock

The European Medicines Agency has issued guidance explaining how good clinical practice (GCP) inspections requested by its human drugs evaluation committee, the CHMP, will be conducted remotely on a case-by-case basis during the COVID-19 pandemic.

The EMA believes GCP inspections are “indispensable” and should, for the present time, focus on the processes and operations of...

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