EMA issues guidance on remote GCP inspections

The European Medicines Agency (EMA) on Wednesday posted new guidance explaining how remote good clinical practice (GCP) inspections should be conducted amid the coronavirus disease (COVID-19) pandemic.
 
EMA says 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) certificates allowing for the possibility of distant assessments during the pandemic. (RELATED: EMA updates on regulatory expectations amid COVID-19, Regulatory Focus 20 April 2020).
 
However, during the pandemic, EMA says that “on-site inspections may not be possible,” due to travel restrictions and health risks for both inspectors and those being inspected.
 
EMA says that inspection teams, with agreement from the Committee for Medicinal Products for Human Use (CHMP), “should make a case-by-case decision on whether a remote inspection is considered appropriate and feasible,” taking into consideration existing procedures for GCP inspections and “limitations imposed by using a remote process.”
 
EMA also acknowledges that remote processes “cannot completely replace on-site GCP inspections,” and says that remote inspections of investigator sites are not feasible.
 
EMA says it is “crucial to avoid any additional burden … on investigator staff at this time” and that local legal requirements for patient data protection could prevent access to source documents.
 
While EMA says that standard procedures for preparing GCP inspections are applicable to remote processes, it notes that preparation “will be significantly more demanding compared to on-site inspections,” and will require early contact with the sponsor or applicant to determine the feasibility of a remote inspection.
 
“It is fundamental to assess whether the inspectee meets the technical requirements to provide remote access to electronic systems and maintain communication with and support to inspectors,” EMA writes, adding that inspectees should provide all requested information and ensure that remote technical support is available for their computerized systems during the preparation phase.
 
If a remote inspection is not feasible, EMA says the rapporteurs should notify it “without delay,” so that the rapporteurs, EMA and CHMP can determine their next course of action.
 
Once a remote inspection is deemed feasible, EMA says inspectors should move to the preparation phase, which should be done according to standard procedures.
 
But EMA adds that, “Remote inspections require a more customised 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.”
 
EMA also stresses that inspectors and inspectees should be in the same location during the inspection, if possible, though local guidelines on remote working should be followed.
 
The guideline also provides recommendations on the conduct of the inspection itself, noting that inspectors must be able to review electronic trial master file (eTMF) audit trails, activity logs and metadata and have access to electronic case report form (eCRF) systems.