Shortcomings in data governance/data integrity and are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services. Additional areas were the subject of FDA investigator attention in CY2017 but may have been overshadowed by these two. This article explores several of those other areas.
Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.
This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements.
This two-part article will address how sponsors can effectively ensure confidence in data integrity at their contract development and manufacturing organizations (CDMOs) and have confidence in the information upon which they base lot release decisions.