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Data Integrity-A Study of Current Regulatory Thinking and Action
Nader Shafiei1, Regis De Montardy2, Edwin Rivera-Martinez3
1Sanofi Global Quality Strategy & Systems, Bridgewater, NJ; Nader.Shafiei@sanofi.com.
PDA Journal of Pharmaceutical Science and Technology
|December 15, 2015
Summary
Regulatory actions address pharmaceutical data integrity breaches. Analysis of 65 cases reveals trends and proposes controls to enhance GxP compliance and public health protection.
Area of Science:
- Pharmaceutical Science
- Regulatory Affairs
- Data Integrity
Background:
- Regulatory agencies worldwide must ensure the integrity of data underpinning medical product approval.
- Breaches in data integrity pose significant risks to public health and regulatory confidence.
- Good Practices (GxP) processes are critical for generating reliable data in pharmaceutical development and manufacturing.
Purpose of the Study:
- To review regulatory actions concerning data integrity breaches in the pharmaceutical industry between 2002 and 2014.
- To analyze current regulatory thinking and identify trends in addressing data integrity issues.
- To explore the role of human factors in data integrity problems and propose remedial controls.
Main Methods:
- Systematic review of 65 regulatory enforcement cases related to data integrity breaches.
- Analysis of regulatory positions, primarily from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
- Examination of human factors contributing to data integrity failures.
Main Results:
- Identified common patterns and themes in regulatory actions against data integrity violations.
- Highlighted the U.S. FDA and EMA's consistent focus on data integrity across GxP areas.
- Underscored the impact of human factors, such as errors and intentional misconduct, on data integrity.
Conclusions:
- Data integrity is a paramount concern for regulatory authorities safeguarding public health.
- Pharmaceutical companies must implement robust controls to prevent and mitigate data integrity breaches.
- Addressing human factors is essential for maintaining data integrity in GxP-regulated processes.
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