Draft Guidance: Data Integrity and Compliance with cGMP

• By: Staff Editor
• Date: November 21, 2016
• Source: http://www.fda.gov/

Draft Guidance: Data Integrity and Compliance with cGMP

US FDA has lately observed increased cGMP violations involving data integrity during inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. These data integrity-related cGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.

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