Remote Inspections - Lessons Learned

In February 2020, travel ceased as the COVID-19 pandemic began to emerge. Since that time, we have come a long way with stay-at-home orders, social distancing, testing, tracing, and quarantine. Countries that implemented aggressive public health measures have had fewer cases and fewer deaths. The regulatory authorities also ceased to travel and were forced to utilize alternative mechanisms to assess industry compliance and review and approve new applications. This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

Until the time of the pandemic, the norm was that inspections would be performed as in-person on-site inspections. In the case of the European Union, Amended Directive 2001/83/EC, article 46(f) (1) explicitly states, “the holder of the manufacturing authorisation shall verify compliance by the manufacturer and distributors of active substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites…” [emphasis added by author].

Read this article in BioPharm International March 2022 Quality and Regulatory Sourcebook eBook.

About the author

James Stumpff, RPh, is principal consultant at Parexel International. Siegfried Schmitt, PhD, is vice president Technical at Parexel International.

Article Details

BioPharm International eBook: Quality and Regulatory Sourcebook, March 2022 Pages: 12-14

Citation

When referring to this article, please cite it as J. Stumpff, S. Schmitt, “Remote Inspections - Lessons Learned," BioPharm International Quality and Regulatory Sourcebook eBook (March 2022).