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# Guidance on Drugs Data Integrity
- URL: https://www.fdaweb.com/guidance-on-drugs-data-integrity/
- Published: 2016-04-15T12:00:00.000Z
- Updated: 2026-09-14T20:55:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135387

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled Data Integrity and Compliance With CGMP. It purpose is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs and is in response to an increase in CGMP violations involving data integrity observed in recent CGMP inspections. When finalized, the draft guidance is intended to provide FDA’s current thinking on creating and handling data in accordance with CGMP requirements. To download this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-15/pdf/2016-08683.pdf?ref=fdaweb.com).