The Food and Drug Administration (FDA) recently released a draft guidance for industry, “Data Integrity and Compliance with CGMP” (Current Good Manufacturing Practices).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
The FDA's New Guidance on Data Integrity
The FDA recently released a draft guidance for industry, "Data Integrity and Compliance with CGMP" (Current Good Manufacturing Practices). 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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