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.
In recent years, the FDA has focused additional resources on efforts to prevent, uncover and combat data integrity lapses. One critical way to help ensure product quality is to prevent data integrity lapses in the first place. 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. These are just some of the steps we take as part of a comprehensive approach to ensuring data integrity.
This new guidance, Data Integrity and Compliance With Drug CGMP: Questions and Answers is an update to our 2016 draft guidance.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.
