The Food and Drug Administration is announcing the availability of a final guidance for industry entitled Data Integrity and Compliance with Drug CGMP: Questions and Answers.  In recent years, FDA has increasingly observed current good manufacturing practice (CGMP) violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, effectiveness, and quality of drugs, and of FDA’s ability to protect the public health. FDA expects that all data to be reliable and accurate. This guidance helps clarify the role of data integrity in CGMP for drugs.  

 

CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Companies 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.  

 

The guidance addresses specific questions about how data integrity relates to CGMP compliance, as well as more general data integrity concepts, in question and answer format.