CDER to Discuss Quality Management Maturity at Meeting
FDA says that its Pharmaceutical Science and Clinical Pharmacology Advisory Committee will review and discuss CDER’s proposed Quality Management Maturity (QMM) program 11/2. Under the program, the Center has proposed implementing a rating system that will help incentivize drug manufacturers to adopt more mature quality management practices at their facilities. “The committee will consider the impact that a QMM program would have on the pharmaceutical industry, drug shortages, and supply chain resiliency,” an agency notice says.
Earlier this year, the agency said it was advancing the framework as part of a Biden Administration 2021 plan to address the vulnerabilities and drug shortages in the nation’s pharmaceutical supply chains (see earlier story). The agency has defined QMM as the “state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.”
Last year, CDER director Patrizia Cavazzoni outlined the principles (see story) behind the Center’s push toward QMM. At the time, she said the agency needs to make sure that manufacturers have more mature quality management systems that “really proactively focus on performance and outcomes that affect the patient, rather than only being focused on ticking boxes, and process metrics…”
A recent white paper said that “(c)hanging the course of pharmaceutical quality by using a QMM rating system is a move toward performance-based regulation of the pharmaceutical industry.” The agency said that a root cause of many drug shortages is the absence of incentives for manufacturers to strive for more than simply meeting GMP regulations and to develop mature quality management systems.
Additionally, FDA said the QMM ratings will be transparent and publicly available, and they likely will be used to “inform regulators and purchasers about the performance and robustness of drug manufacturing facilities and give patients increased confidence in the availability of drugs. FDA also believes drug purchasers will benefit greatly by increased quality transparency at firms which in turn will lead the drug industry striving to improve its quality rating. QMM ratings could also support increased flexibility for manufacturers to make postapproval manufacturing changes with less regulatory oversight, incentivizing continual improvement.”
According to the notice, the advisory committee on the next day (11/3) will hear FDA updates on the next stages of Knowledge-Aided Assessment and Structured Application (KASA). Previously, the agency described 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. In addition, it will perform computer-aided analyses of applications to compare regulatory standards and quality risks across applications and facilities.
At the panel meeting, FDA says it will seek input on the vision and plan to expand KASA over the next five years to include drug substances, all generic dosage forms, new drug and biologics applications, and post-approval changes. “Moreover, FDA will seek input regarding the need for advancing digitalization in KASA, including data standardization and mobilization of data from cloud- based servers,” it says.