Data Integrity and the Pre-Approval Inspection: An Inspector’s Experience

Data Integrity and the Pre-Approval Inspection: An Inspector’s Experience

By: John R. Godshalk, MSE, MBA, Senior Consultant

Overview

Data integrity has always played an essential role in regulatory application review and cGMP inspections – a trend that will only continue to grow in the coming years. The FDA’s April 2016 draft guidance document "Data Integrity and Compliance with cGMP” is an important step by the Agency to clarify its current thinking and policy regarding data integrity moving forward.

In this paper, John R. Godshalk chronicles the issues he has encountered with data integrity in pre-approval inspections and reflects on related points in the Agency’s April 2016 draft document. He also guides readers through common data integrity mishaps and provides useful tips and best practices for avoiding them.

This paper explores:

  • An overview of the recent FDA guidance “Data Integrity and Compliance with cGMP”
  • The intent of the pre-approval inspection and how data integrity plays a role
  • First-hand accounts of common data integrity issues in the pre-approval process
  • The importance of audits and responding to data integrity issues
  • Advice and best practices for ensuring data integrity

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About the Author

John R. Godshalk, MSE, MBA is a senior consultant at Biologics Consulting. Prior to joining the Biologics Consulting team in 2005, John served as a Senior Review Biochemical Engineer and Lead cGMP inspector for the Division of Manufacturing and Product Quality at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) for 3 ½ years.

With more than 15 years of experience in cGMP, regulatory affairs and management consulting, John assists clients with a wide range of cGMP and regulatory projects.