Abstract
The COVID-19 pandemic forced industry and national regulatory authorities (NRAs) to think about innovative ways to ensure business continuity, including Good Manufacturing Practices (GMP) inspections. Even prior to COVID-19, it was understood that GMP site inspections, especially redundant inspections, are a time and resource-intensive process for both industry and regulators in high-income countries and often prohibitive to resource-challenged countries. Thus, we investigated the use of a mixed reality device and Microsoft (MS) Teams as a platform for mixed reality (hybrid) remote inspection. This pilot involved a mock GMP inspection of a drug manufacturing facility in the United States. The mock inspection was conducted by two former USFDA (US Food and Drug Administration) investigators, facilitated by representatives from Northeastern University along with The Bill and Melinda Gates Foundation. Also participating in the inspection were inspectors from national regulatory agencies (NRAs) from the African continent, including Nigeria, South Africa, Uganda, and Zimbabwe, and representatives from the Pre-Qualification Inspection Unit at the World Health Organization (WHO). Harmonized inspectional guidance from PIC/s (GMP Guide) and WHO (TRS 823) were used as the standards for conducting the mock inspection. We found that mixed reality, used in conjunction with a collaborative text messaging system, is a viable tool to facilitate remote inspections and allows inspectors participating remotely to write their own independent inspection reports.