Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

Issue link: https://www.e-digitaleditions.com/i/1462155

Contents of this Issue

Navigation

Page 27 of 54

28 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Regulations: Inspections I n 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 in- dustry 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]. Alternative inspection forms (i.e., remote inspections) weren't fore- seen. As there is no globally accepted definition of such an inspection form, the authors will refer to what is provided in the Parenteral Drug Association's (PDA's) Points to Consider in Remote and Hybrid GMP/ GDP Inspections document (2): • "Remote inspection: An inspection in which the inspector is not physically present at the site(s) where the activities subject to the assessment take or have taken place. Remote inspections Remote Inspections— Lessons Learned James Stumpff and Siegfried Schmitt 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. James Stumpff, RPh, is principal consultant at Parexel International. Siegfried Schmitt, PhD, is vice president Technical at Parexel International. K ADMY - STOCK.ADOBE.COM

Articles in this issue

Links on this page

Archives of this issue

view archives of Pharmaceutical Technology - March 2022 - Pharmaceutical Technology March 2022