This presentation describes a new FDA’s pharmaceutical quality assessment system: Knowledge-aided Assessment & Structured Application (KASA). The KASA system is designed to: 1) capture and manage knowledge during the lifecycle of a drug product; 2) establish rules and algorithms for risk assessment, control, and communication; 3) perform computer-aided analyses of applications to compare regulatory standards and quality risks across applications and facilities; and 4) provide a structured assessment that minimizes text-based narratives and summarization of provided information. When fully developed and implemented, KASA will enrich the effectiveness, efficiency, and consistency of regulatory quality oversight through lifecycle management of products and facilities, and information sharing in a standardized and structured format. Ultimately, KASA will advance FDA’s focus on pharmaceutical quality, the foundation for ensuring the safety and efficacy of drugs.
Discuss factors that prompted the vision and development of the Knowledge-aided Assessment and Structured Application (KASA) initiative
Discus the critical components of the KASA system, and the benefits KASA could provide to improve the efficiency, consistency, and objectivity of regulatory actions.
llustrate the implementation of KASA and its implications on product quality assessment.