ISSN: 2642-6315
Authors: Prasanthi D*
The regulatory evaluation process used by the FDA has changed through time, moving from a summary-based review in the 1990s to a question-based review and risk-based approach in the 2000s, and finally to an integrated quality assessment in 2015 and beyond. While attempting to ensure effectiveness, uniformity, and objectivity in its oversight of pharmaceutical quality, the FDA has faced difficulties. The FDA is developing a new approach called Knowledge-aided Assessment & Structured Application (KASA) to address these issues and make the most of technological advancements. The KASA system is intended to: 1) capture and manage knowledge throughout the lifecycle of a drug product; 2) develop 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 reduces textbased narratives and summarization of provided information. KASA is a new system designed to update the regulatory drug applications’ quality evaluation. KASA represents a conceptual change away from the out-dated evaluation procedures and toward a fresh, more effective method of managing data and resources. When completely developed and put into use, KASA will improve regulatory quality oversight’s efficacy, efficiency, and consistency through the lifecycle management of products and facilities and the sharing of information in a standardized and organized format. KASA will ultimately increase FDA’s emphasis on pharmaceutical quality, which is the cornerstone for guaranteeing the safety and efficacy of medications.
Keywords: KASA; Quality Assessment; Pharmaceutical Quality; Knowledge-Aided Assessment; OPQ
