The US Food and Drug Administration (FDA) has issued final guidance, Data Integrity and Compliance With Drug CGMP, which updates a 2016 guidance for ensuring data integrity and compliance with current good manufacturing practice (CGMP), in response to public comments requesting additional details on the FDA’s thinking on current best practices.

The guidance covers the design, operation, and monitoring of systems and controls to maintain data integrity. The agency revised the guidance in response to public comments requesting additional details on the agency’s thinking on current best practices. The revised 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. The principles are relevant to manufacturing employees and management.

“With the emergence of new markets, supply chains are more complex,” FDA Commissioner Scott Gottlieb said in a December 12, 2018 agency statement. “Drug production and testing operations have also become more computerized. These changes represent new opportunities and challenges. To meet these challenges, our policies and guidance must also evolve to ensure that quality standards are maintained, and to assist companies in building a culture of quality. To that end, one area we’ve focused new attention on in recent years is data integrity. Our goal is to ensure that the data associated with drug manufacturing are complete, consistent, and accurate, and therefore reliable.”

This new guidance, Data Integrity and Compliance With Drug CGMP: Questions and Answers, is one part of the FDA’s multi-layered approach to help ensure the integrity of data. The agency also uses inspections to uncover data integrity problems. For example, its pre-approval inspection process is used to help ensure the integrity of data by evaluating, among other factors, its proper storage and handling. In tandem with pre-approval inspections, the FDA also conducts assessments of drug applications prior to approval and when companies submit information about changes to their manufacturing processes.

 “Sometimes, data integrity concerns are a result of deceptive practices. But more commonly, they’re a result of inadequate processes and systems to ensure reliable and accurate data,” Gottlieb said in his statement. “One critical way to help ensure product quality is to prevent data integrity lapses in the first place. That’s why we’ve worked to provide industry with clear guidance, so manufacturers have the tools and systems in place to prevent adulterated products from entering the U.S. marketplace. Companies need to create a quality culture where employees understand the seriousness of data integrity and promote data integrity as a core value. A work environment where employees are encouraged to promptly identify and properly report data issues is essential to product safety.”

Source: FDA (announcement), FDA (final guidance)