USA – FDA Explains Plans for New Pharmaceutical Quality Assessment System

As part of its work to improve and modernize the quality assessment of drug applications, the US Food and Drug Administration (FDA) is developing a new, more standardized system, to be known as the Knowledge-aided Assessment & Structured Application (KASA), according to an article authored by officials from FDA’s Center for Drug Evaluation and Research and published in the latest issue of the International Journal of Pharmaceutics.

The authors describe KASA as a new system that captures and manages information in a structured format about the inherent risk and control approaches for product design, manufacturing and facilities.

The system is meant to help FDA address challenges related to its quality assessments. The authors note that when a quality assessor currently reviews a regulatory application, “it is not possible to easily locate historical data about similar products, processes, or the facilities. Such a practice has significantly reduced the efficiency of the regulatory assessment and increased the likelihood of inconsistencies. Further, in particularly urgent cases, the FDA may not have readily available up-to-date information to provide timely, thorough, and complete responses, hindering FDA’s regulatory oversight.”…