Remote inspections are the new normal, say global regulators
BASEL, Switzerland – Remote or virtual inspections are now permanent fixtures in the toolboxes of the World Health Organization (WHO) and the European Directorate for the Quality of Medicines (EDQM) as they assess the pharmaceutical industry’s compliance with good manufacturing practices (GMPs). While this inspection method was once viewed as a temporary tool to counteract travel restrictions wrought by the pandemic, they are now viewed as a routine method of inspecting.Regulators also asserted that prioritizing inspections is now a necessity to address the growing backlog of onsite inspections that had to be put on hold during the pandemic.
These were some of the lessons shared by a panel of regulators who spoke at DIA Europe 2023.
EDQM: Remote inspections are here to stay
Christine Baccarelli, a GMP inspector with EDQM, said that starting in 2022, the agency’s Real-Time Remote Inspections (RTEMIS) pilot project became a permanent part of the agency’s inspection toolbox after pandemic-provoked travel bans interrupted onsite inspections in March 2020. The pilot project was designed to assessthe use of real-time document sharing and live video feeds.
EDQM previously hinted that real-time remote inspections could serve as a third pillar for assessing active pharmaceutical ingredient (API) manufacturers at the end of a pilot testing its use (RELATED: Euro Roundup: EDQM say remote inspections could be third pillar for GMP oversight, Regulatory Focus, 8 July 2021)
“After evaluating the results and achievements obtained during the pilot phase of the remote inspections project, the EDQM has concluded that RTEMIS approach is suitable to become an integral part of the system of supervision of manufacture of active substances,” said Baccarelli.
She said the process flow for remote assessments is the same for onsite inspections: if GMP deficiencies are found, EDQM will issue a notice to applicants within six weeks of the inspections.
Baccarelli said that remote inspections can now be used in multiple circumstances not related to the pandemic. They can now be used if there are potential safety concerns in a destination country or can be used to assess sites that have a good track record of GMP compliance. Or they can be used to verify that corrective and preventive actions (CAPA) have been implemented or can be used in cases where immediate assessments are needed to assess specific situations that might pose a risk to public health before an onsite inspection.
WHO prequalification program uses mix of inspection methods
Stephanie Croft, a technical officer with WHO, said the organization’s prequalification inspections program now includes a mix of onsite inspections, desktop assessments and remote assessments. Among the sites they assess are vaccine manufacturing sites, medical laboratories and sites that manufacture IVD tests.
Croft said that in 2019, WHO conducted 200 inspections, 140 of which were onsite. As the pandemic took hold, however, the number of onsite inspections dwindled in 2020 and 2021. In 2020, 183 of WHO’s prequalification assessments were done as desktop assessments, the “largest number we ever did.” WHO conducted four remote assessments in 2021. Croft said that “we hope this number will increase in the future as we optimize our approaches.”
She said that “we have not fully recovered from COVID, and we were not able to inspect all the Chinese sites in 2022, so it is really challenging to catch up with the backlog.”
To address the backlog, she said it is important to prioritize inspections. She said that “it has never been more important to prioritize sites.”
Higher risk is accorded to those firms that make sterile drugs as well as sites that produce a high volume of drugs. Other factors taken into consideration include the firms’ compliance history, the number and nature of complaints directed at the firm and whether the assessor has noticed prior data integrity violations.
Croft added that whichever tool is used, WHO collaborates heavily with other regulatory partners, including the Pharmaceutical Inspections Scheme (PIC/S), the European Medicines Agency (EMA), the International Coalition of Medicines Regulatory Authorities (ICMRA), and EDQM.
“At every stage or whatever tool we use, we rely strongly on international collaborations in order to optimize our resources and to be more effective in what we do. For instance, for an onsite inspection, before we confirm a site on our schedule, we always gather intelligence about the site by contacting our regulatory partners,” she said, adding that they contact manufacturers to see if any inspections have been announced by other authorities within six months.
From 2019 to September 2022, most of the EDQM inspections took place in India, followed by China, African countries, Pakistan, Bangladesh, Egypt and Indonesia.
DIA Europe 2023
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