Remote GCP Inspections

The European Medicines Agency (EMA) released a new guidance explaining how remote Good Clinical Practice (GCP) inspections should be conducted during the COVID-19 pandemic.
 
The EMA emphasizes that GCP inspections are indispensable to its assessment of marketing authorization applications, especially during a public health crisis. European authorities have previously provided guidance on Good Manufacturing Practice (GMP) inspections allowing for the possibility of remote assessments.
 
The agency says that on-site inspections may not be possible due to travel restrictions and health risks for both inspectors and those being inspected. Therefore a case-by-case decision on whether a remote inspection is considered appropriate and feasible should be made. If a remote inspection is not considered to be feasible, the inspection team shall communicate this fact without delay, so that the rapporteurs, EMA and the CHMP (Committee for Medicinal Products for Human Use) can determine their next steps.

Access to Electronic Systems and Review of Audit Trails

During a distant GCP inspection it is necessary to provide remote access (and technical support) to electronic systems and maintain communication with the inspectors. Once a remote inspection is considered to be feasible, the inspectors should move to the preparation phase, which should be done according to standard procedures. However, the EMA states that, "Remote inspections require a more customized preparation by the inspectee and the inspection team as compared to on-site inspections." The agency also notes that remote inspections can take longer than on-site inspections "given the particularities of this type of inspection and the fact that inspectors may need to control several systems simultaneously while conducting the inspection."
 
The guideline also provides recommendations on the conduct of the remote GCP inspection itself, noting that inspectors should be able

  • to access the crucial electronic systems, especially the eTMF (electronic Trial Master File) and the eCRF (electronic Case Report Form),
  • to review the eTMF related Audit Trails, activity logs and metadata,
  • to use export / save functions to retrieve documents from the eTMF.

More information can be found at EMA´s Website on Good clinical practice (GCP) inspection procedures.

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