Statement from FDA Commissioner Scott Gottlieb, M.D
Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. Overseeing the quality and safety of pharmaceutical manufacturing is key to these efforts. With the emergence of new markets, supply chains are more complex. Drug production and testing operations have also become more computerized. These changes represent new opportunities and challenges.
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. 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.
Over the past decade, we’ve uncovered situations in which drug quality data and information are not accurate. This can mask problems and failures. 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. In all cases, we regard any lapse in data integrity as a risk to patient safety. Patients can’t be assured of the safety and effectiveness of their medication when data has been altered.
In recent years, the FDA has focused additional resources on efforts to prevent, uncover and combat data integrity lapses. We’ve focused new efforts on these risks, and to train our staff on identifying concerns related to data integrity. Today, we’re building on these policies by updating our guidance for industry on ensuring data integrity and compliance with current good manufacturing practice (CGMP).
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.
This new guidance is one part of our multi-layered approach to ensuring the integrity of data. We also use inspections to uncover data integrity problems. For example, our 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, we also conduct thorough assessments of applications prior to approval and when companies submit information about changes to their manufacturing processes.
These are just some of the steps we take as part of a comprehensive approach to ensuring data integrity.
As the industry has globalized, we’ve expanded our partnerships with our international regulatory counterparts. This allows us to regularly exchange information about quality and data integrity related violations if they’re observed in facilities around the world. We also communicate regularly with the global industry participants to advance best pratices on data security to help manufacturers advance their own compliance policies.
Our new guidance document is aimed at promoting these efforts.
This new guidance, Data Integrity and Compliance With Drug CGMP: Questions and Answers is an update to our 2016 draft guidance. 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 our 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.
We continue to observe CGMP violations involving data integrity, which underscore the need to provide industry with guidance and address observed problems. When we see these violations, we take appropriate enforcement actions against manufacturers. We also expect all manufacturers to conduct timely and appropriate investigations of suspected problems, including expanding the scope beyond the narrow problem first observed into any other potentially impacted data, batches, or products. Pharmaceutical quality can only be assured by robust quality control, which includes vigilant oversight of data integrity.