Regulators recommend remote inspections for use post-pandemic
Posted: 13 December 2021 | Hannah Balfour (European Pharmaceutical Review) | No comments yet
A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
A new review by a working group at the International Coalition of Medicines Regulatory Authorities (ICMRA), recommends the use of remote inspections as a complementary tool to on-site inspections beyond the COVID-19 pandemic.
COVID-19 has necessitated a change to the world’s working habits, and pharmaceutical industry regulators are no exception. To maintain regulatory oversight of both good clinical practice (GCP) and good manufacturing practice (GMP) activities, regulators worldwide adopted remote assessments, using video conferencing software and devices to enable continuity of compliance oversight. Such technologies enabled the remote conduct of inspections, evaluations and assessments of certain activities and sites, even as the world was locked down with social distancing and travel restrictions.
While the group stated that remote inspections were an “enabling tool” that allowed the maintenance of “at least a minimal regulatory oversight during the pandemic, it is not the view of the group that remote inspections would fully replace an on-site inspection programme”. This, they explained, is because of limitations with the current technologies that hampered remote assessment of compliance.
According to the authors, using the remote approach to augment typical in-person visits could be beneficial in post-pandemic times, but that the extent of its use in situations outside of a public health emergency would need to be evaluated.
It is worth noting, not all inspections were undertaken remotely during the pandemic: on a case-by-case basis regulators assessed the need for inspections and whether a remote approach would be suitable. If a remote evaluation was deemed insufficient, inspections were either postponed until conditions allowed for an on-site visit, or a hybrid approach leveraging both on-site and remote means was adopted.
The full reflection paper, outlining all the remote oversight approaches adopted – ranging from sharing of documents and access to the relevant electronic systems, to facility tours and data reviews etc – as well as the limitations encountered and other key findings can be accessed here: https://www.icmra.info/drupal/sites/default/files/2021-12/remote_inspections_reflection_paper.pdf
