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 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 the 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 the 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 the FDA’s regulatory oversight.”
But with KASA, certain rules and algorithms will be able to estimate the initial inherent product and manufacturing risks.
“After the assessor enters information in the system based on the application, a failure modes, effects and criticality analysis (FMECA) approach is employed. This is used to objectively and quantitatively assess and rank risks associated with the failure modes of drug product design and manufacturing. These are the risks that have the greatest chance of causing product and manufacturing failure or unexpected harm to the patient,” FDA officials explain.
KASA also will help with risk controls related to product design and manufacturing.
In addition, the CDER officials note that although KASA is being primarily developed as an assessment tool, “it is capable of alleviating problems” associated with the submission of drug applications via the electronic common technical document (eCTD) format.
In the future, the submission structure recommendations, such as those initiated for standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data and terminologies could be made to interface with KASA’s structured assessment approach. “Under this paradigm, automated tools would be used to populate the KASA template from the structured submission with, for example, specifications and critical process parameter ranges,” the article notes.
As far as the major benefits of this shift to a KASA system, the authors note that it “moves 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.”
So, when is KASA coming?
The article did not provide a timeline, but the FDA said last September that a draft guidance would be released for industry comment before anything takes effect.
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.