CDER Implementing KASA Drug Quality Tool
CDER’s Office of Pharmaceutical Quality (OPQ) says that early this year it will begin using its Knowledge-aided Assessment & Structured Application (KASA) tool for solid oral dosage forms, manufacturing, and biopharmaceutics regulatory assessments. KASA has been under development for years to improve efficiency, effectiveness, and quality assessment consistency by structuring quality-related data it receives, maintaining a collective knowledge base of the data, and enabling a more consistent scientific assessment of risk associated with applications, the agency says.
In a just-posted OPQ annual report, the office says it “developed and tested new knowledge-aided assessment interfaces for drug substance information and liquid dosage form ANDAs. We also started to develop interfaces for INDs and BLAs.” While KASA’s structured application element is still being developed, OPQ says its eventual use is expected to provide more regulatory efficiency, increased consistency between submissions, and faster availability of quality products.
A year ago, FDA outlined the KASA system as moving “regulatory application assessment from the current unstructured text document to an issue-based regulatory and technical assessment using structured data and information with standard formatting, a common vocabulary, and a uniform output. In turn, this improves consistency, transparency, communication, and objectivity of regulatory actions, as well as knowledge management within the agency.” KASA is also intended to establish rules and algorithms for risk assessment, control, and communication. It will also perform computer-aided analyses of applications to compare regulatory standards and quality risks across applications and facilities.
OPQ’s report also acknowledged the Covid–19 impacts on its functions — assessment, inspection, research, surveillance, and policy. “Although Covid–19 travel restrictions postponed non-mission-critical facility inspections, OPQ staff made use of alternative tools for manufacturing facility assessments, avoiding the need to conduct 153 on-site facility inspections prior to approving applications,” it says. Staff in OPQ laboratories in Maryland and Missouri “continued to conduct mission-critical testing and research, leading to product recalls and import alerts keeping pharmaceutical markets safe for consumers. OPQ staff provided critical support for establishing which FDA inspections were deemed mission critical and understanding where essential medicines are manufactured.”
Additionally, the report touches on activities under CDER’s Emerging Technology Program (ETP) to support advanced manufacturing. “To encourage innovation, the ETP allows early engagement with the FDA, even before identifying a drug candidate, if an innovative advanced manufacturing technology will be used,” it says. “Early engagement allows us to proactively identify and resolve potential scientific and policy issues related to these new technologies and helps applicants minimize regulatory uncertainty.”
Last year, the office says ETP received nine regulatory submissions, accepted 16 new proposals, and held 40 industry meetings. “To strengthen our knowledge base on advanced manufacturing, over $13 million in extramural research funding in 2020 enabled OPQ staff to collaborate with academia and industry studying and developing these new technologies.” It notes that the National Academies of Sciences, Engineering, and Medicine held two workshops in 2020, to identify innovations on the horizon in the next five to 10 years in the pharmaceutical industry and to identify barriers to implementing those innovations.