Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device.

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,

SUBMITTER: Baker P 

PROVIDER: S-EPMC10764403 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature