Samsung Biologics, a contract development and manufacturing organization (CMDO), celebrated the one-year mark of Live Virtual Tour (LVT), a platform to provide remote site inspections for clients and regulatory agencies. The tool was developed and implemented at Samsung Biologics a year ago in the wake of the pandemic. Since then, 50+ virtual regulatory and client audits and inspections have been completed with the software.
Many regulatory agencies and clients postponed or discontinued GMP site inspections due to COVID-19 travel restrictions. Samsung Biologics proactively innovation to create a remote solution to address the demands of a biopharmaceutical onsite inspection. Live Virtual Tour is an omni-device platform that allows third parties, such as the FDA and clients, to remotely observe and assess Samsung Biologics’ facilities, communicate in real-time, and review GMP documentation, all in high definition using cloud infrastructure.
Since the launch of LVT, the company has utilized the platform for many aspects of its business, including technical due diligence and regulatory inspections including one of FDA’s earliest virtual assessment for Emergency Use of Authorization (EUA) of COVID-19 treatments.
John Rim, CEO of Samsung Biologics, said of the inspections, “We will continue to adopt new technologies and stay abreast of what regulatory authorities require to help our clients secure robust and safe delivery of treatments to all patients around the globe.”
The FDA issued a new recommendation in April providing guidance on remote inspections (“Remote Interactive Evaluations”) in light of COVID-19, suggesting that the FDA may continue to use remote inspections to supplement on-site audits post-pandemic. The European Federation of Pharmaceutical Industries and Associations (EFPIA) also expects a virtual inspection system to continue beyond the pandemic.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from Pharmaceutical Outsourcing – all delivered right to your inbox!
Sign up now!