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GUIDANCE DOCUMENT

Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry Guidance for Industry December 2018

Final Level 1 Guidance
Docket Number:
FDA-2018-D-3984
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Policy
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Data Integrity and Compliance With Drug CGMP: Questions and Answers.’’ The purpose of the guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. (Unless otherwise noted, the term CGMP refers to CGMPs for drugs, including biologics.) The guidance has been developed in response to an increase in findings of data integrity lapses in recent inspections. FDA expects that all data be reliable and accurate. CGMP regulations and guidance allow for flexible and riskbased strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective
strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-3984.