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Digitization of Validation for Effective Off-site Regulatory “Review” and “Inspection”

Blog Home | Published: February 9, 2021

Originally published on IVT Network (www.ivtnetwork.com) | Journal of GxP Compliance | Volume 25, Issue 1 January 2021

In the on-going COVID-19 pandemic, the U.S. Food and Drug Administration has postponed domestic and foreign routine surveillance inspections on a case-by-case basis; it is prioritizing mission-critical inspections that it seeks to conduct with appropriate safety measures in place. In the broader context of extreme uncertainty and emergency use principles, the FDA is relying on firms to self-regulate – “we believe most FDA-regulated firms understand and appreciate their responsibility to ensure the safety of the products they manufacture or produce. We consider these firms to be our partners in public health” (1,2).

It is unlikely that we will return to the pre-pandemic “normal” course of regulatory inspection for some time; perhaps, the remote, virtual, “office-based” inspections may now be a part of the norm across the ICH region (3,4). This alternate means of inspections will, among other things, require firms to provide electronic copies of documents and additional information for off-site regulatory “review” with follow-up tele/video conferences and email. Inspecting and investigating deviations from Good Laboratory, Clinical, and Manufacturing Practices is a distinct complementary function to off-site regulatory review of documents supplied by a company. There is a need to appreciate the value of this distinction and to progress evidence-based policies and procedures incorporate technological solutions that provide remote “hands-on” and “eye-on” interactive inspectional capabilities.

Paperless validation systems are already in place at many facilities. They can be utilized for interactive inspections and provide opportunities for regulators and companies to improve efficiencies and provide assurance to patients. This paper outlines key advantages and points to consider for leveraging a paperless validation platform to enhance the efficiency of remote pre-approval and pre-license remote inspections.

Click here to access the complete article.

Summary

In the on-going COVID-19 pandemic, the U.S. Food and Drug Administration has postponed domestic and foreign routine surveillance inspections on a case-by-case basis; it is prioritizing mission-critical inspections that it seeks to conduct with appropriate safety measures in place.



Author

Dr. Ajaz Hussain

Dr. Ajaz Hussain is a distinguished contributor and acknowledged leader in the advancement of pharmaceuticals, regulatory science, and drug development. During Dr. Hussain’s tenure at the FDA, as Deputy Director, Office of Pharmaceutical Science, he led the FDA efforts on Process Analytical Technology (PAT) Initiative and CGMPs for the 21st Century. He was the FDA’s lead for Quality ICH negotiations and the establishment of the ICH initiative on Pharmaceutical Quality for the 21st Century (ICH Q8, Q9, and Q10). He has served as the President of the National Institute for Pharmaceutical Technology & Education (a not-for-profit collaboration among leading American universities), as the principal of his consulting company Insight, Advice & Solutions. He has also held several senior management positions including CSO & President of Biotechnology at Wockhardt, Chief Scientific Officer at Philip Morris International, VP & Global Head of Biopharmaceutical Development at Sandoz, and Associate Professor of Pharmaceutics at the University of Cincinnati’s College of Pharmacy.