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Data Integrity Guidance Adds Focus On Culture, Best Practices And APIs

 
• By Joanne S. Eglovitch

In response to comments, US FDA’s final guidance on data integrity further refines and expands on some of the principles and best practices espoused in the draft version to help pharmaceutical manufacturers counter a growing problem with inaccurate data. This problem continues to consume a good deal of FDA’s GMP enforcement efforts.

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FDA’s final guidance on data integrity stresses the importance of a strong quality culture and a lifecycle approach to data management to ward off potential threats of data manipulation.

The Dec. 12 guidance, called “Data Integrity and Compliance With Drug cGMP: Questions And Answers,” amends an April 2016 draft version by adding a new set of best practices...

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