Data Integrity continues to be one of the hottest topics in our industry and for very good reason. Without the necessary systems and/or processes in place to ensure data integrity throughout the product lifecycle, product quality and patient safety issues are more difficult to detect and therefore mitigate in a timely fashion.
It is important to understand what data integrity really means in order to be compliant. Essentially, it refers to the fact that data must be reliable and accurate over its entire lifecycle. Data integrity and data security go hand in hand, even though they’re separate concepts. Uncorrupted data (integrity) is considered to be whole and then stay unchanged relative to that complete state.
Quality metrics, quality culture, and data integrity are of particular concern to both the industry and regulatory authorities. Pharmaceutical Online has published an interesting history of how these three areas have come together in establishing current global regulatory expectations.
Quality metrics are used throughout our industry to drive continuous improvement efforts in manufacturing. Collecting the right quality metrics is critical to ensure compliance. Quality metrics can also help the FDA in developing compliance and inspection policies and procedures by allowing the FDA to:
Use a risk-based inspection scheduling of drug manufacturers
Improve ability to predict and possibly mitigate future drug shortages
Encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for manufacturing.
The revised draft guidance includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation.
FDA is initiating a voluntary reporting phase of the FDA quality metrics reporting program where they expect to learn more about a limited set of quality metrics, associated analytics, and improve the FDA quality metrics reporting program.
During the voluntary phase of the reporting program, FDA will accept voluntary submissions of data from drug manufacturing firms involved in the manufacture, preparation, propagation, compounding, or processing of finished dosage forms (FDF) or active pharmaceutical ingredients (API) used in the manufacture of “covered drug products.”
For more information and to download the guidance, click here.