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Thursday 7 March 2019

The FDA's focus on Data integrity does not decrease: 18 questions and answers on the data integrity and governance.

The FDA took more than two years to publish the official version of its guidelines on Data Integrity "Data Integrity and Compliance with Drug CGMP Questions and Answers", finalizing the draft issued in April 2016.


The guideline is applicable to drugs, biological drugs and drugs for positron emission tomography. The agency also states that the requirements are consistent with the requirements of the ICH Q7, "Guide to Good Manufacturing Practices for Active Pharmaceutical Ingredients", thus expanding the scope of the document to APISOSTANZA STU and controlled substance.


The initial introduction to the context summarizes the GMP requirements underlying the Data Integrity taken from 21 CFR 211. It is a very useful aid for GMP auditors when they mention the standard associated with their observations and examples. The rest of the guideline consists of 18 questions regarding data integrity and data governance.


Read the article in PDF which summarizes and explains the fundamental points of the guide (ITA)

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