Devendra
Mishra
Executive Director
BSMA
VIRTUAL AUDIT: A POSITIVE OUTCOME OF THE COVID-19 PANDEMIC
The belief that necessity is the mother of invention has been reaffirmed with the FDA conducting Virtual Audits of drug manufacturers in a widespread stay-at-home ordinance across the nation. Exacerbated by travel restrictions and hot zones for infections, companies find themselves somewhat paralyzed to carry out the audit mandated by the FDA as well as its own audit of suppliers. The FDA has come to the rescue by allowing digital video and communication technologies to minimize the need for traditional in-person audits. It is still necessary for each organization to ensure that their suppliers continue to provide services and materials that are fit for purpose and in compliance with quality expectations, where the GxP audits are continued to verify that organizations comply with processes and guidelines. As a matter of fact, virtual audits will enhance the traditional audit practices which must be rigid and robust by incorporating significant cost efficiencies.
In March of 2020, the FDA announced it was scaling back foreign and domestic surveillance facility inspections and relying instead upon, among other measures, reviewing records remotely—an authority granted in section 706 of FDASIA amendments of 2012 to the FD&C Act. On July 10th,
