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The FDA's New Guidance on Data Integrity

By Alan G. Minsk

The Food and Drug Administration (FDA) recently released a draft guidance for industry, “Data Integrity and Compliance with CGMP” (Current Good Manufacturing Practices). See http://1.usa.gov/25IzpM4. While the draft is not legally binding on industry or the agency, it offers the FDA's current thinking on how drug and biologic manufacturers can comply with current Good Manufacturing Practices, to ensure completeness, consistency, and accuracy of data. In recent years, FDA has taken numerous enforcement actions against companies for data integrity-related violations during GMP inspections. In addition to describing the agency's expectations, the document also offers companies a means to reduce potential product liability exposure.

This article highlights some of the key points in the guidance and attempts to identify the agency's central concerns and recommendations.

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