FDA Releases Data Integrity Guidance

On April 14, 2016, FDA published Data Integrity and Compliance with CGMP, which addresses the role of data integrity in CGMP for drug manufacturing, finished pharmaceuticals, and positron emission tomography drugs, as required by 21 Code of Federal Regulations (CFR) parts 210, 211, and 2012. The guidance has been issued in response to an increasing amount of data integrity violations found by the agency during CGMP inspections. According to FDA, data integrity CGMP violations have led to FDA warning letters, import alerts, and consent decrees. The new guidance answers data integrity questions in the hope of clarifying what FDA expects from manufacturers.

The guidance states that data should be reliable and accurate, and companies should implement effective strategies to manage data integrity risks. Along with clarifying the definition of data integrity terms, the guidance addresses the exclusion of CGMP data, workflow validation, data access, audits, electronic records, and personnel training. FDA also clarifies sampling and testing requirements and how to address data integrity problems.