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

The Food and Drug Administration (FDA) created a questions and answers document to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, due to an increase in CGMP violations involving data integrity during CGMP inspections. The FDA expects that all data meet the ALCOA principles following a risk-based approach. This questions and answers document applies to the data integrity (DI) of drugs (including biologics), as required in 21 CFR parts 210, 211, and 212 and was effective December 2018.

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