Guidance on Remote GCP Inspections During the COVID-19 Pandemic

On 10 June 2020 the EMA announced that guidance is available for inspectors on how to initiate and conduct remote inspections to verify compliance with GCP standards during the COVID-19 pandemic.

The guidance covers all phases of remote GCP inspections, with a particular focus on the more challenging aspects, such inspection initiation, feasibility assessment and preparation.

Remote inspections should follow the applicable procedures that already exist for coordinating, preparing and conducting GCP inspections requested by the Committee for Medicinal Products for Human Use (CHMP), but should also take into consideration the limitations imposed by using a remote process and recognise that such a remote process cannot completely replace on-site GCP inspections.

The purpose of this document is to outline the requirements and specificities of remote GCP inspections identifying the points to be considered during the preparation, conduct, and reporting phase in this context.

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