FDA efforts to improve drug quality through oversight of data integrity and good manufacturing practice

FDA Commissioner Scott Gottlieb says overseeing the quality and safety of pharmaceutical manufacturing is key to efforts to ensure the safety of the nation's drug supply.

FDA Commissioner Scott Gottlieb says overseeing the quality and safety of pharmaceutical manufacturing is key to efforts to ensure the safety of the nation's drug supply. Having clear guidelines for companies on how to prevent product quality issues is an important step to protecting patient safety and preventing drug shortages of critical medicines. One area the agency has focused new attention on in recent years is data integrity, in an effort to ensure that the data associated with drug manufacturing are complete, consistent, and accurate. FDA is now updating its guidance for industry on ensuring data integrity and compliance with current good manufacturing practice. The new guidance, "Data Integrity and Compliance With Drug CGMP: Questions and Answers," is an update to FDA's 2016 draft guidance. The guidance covers the design, operation, and monitoring of systems and controls to maintain data integrity. The updated recommendations are aimed at helping manufacturers address identified data integrity lapses, implement best practices to address gaps that can create risks to data integrity, and ensure consistent awareness and commitment to ensuring data integrity.