FDA to Rate Drug Firms’ Quality Management Maturity
FDA says it is advancing a framework to objectively rate pharmaceutical manufacturing sites’ Quality Management Maturity (QMM). The program is 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 just-released whitepaper says 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 says 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.
FDA says 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,” it says.
The whitepaper hints that QMM ratings will go beyond GMP inspections to “measure how far a site’s pharmaceutical quality system (PQS) rises above the minimum requirements. Simple adherence to CGMP standards does not indicate, for example, that a firm is investing in improvements to prevent supply disruptions.”
The agency recommends pharmaceutical makers use the ICH Q10 Pharmaceutical Quality System guidance to understand the concept of an effective pharmaceutical quality system over the lifecycle of a product. It says it “describes activities to manage and continually improve the PQS (the elements), using knowledge management and quality risk management principles (the enablers).” FDA notes that an effective PQS is necessary for firms desiring to use the tools described in ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product LifecycleManagement for evaluating regulatory flexibility related to chemistry, manufacturing and control change reporting requirements (see related story).
Additionally, the whitepaper connects the effective use of quality metrics as one characteristic of robust site QMM. This explains FDA’s renewed interest in quality metrics and its notice last month seeking comments on specific aspects of changes it is proposing to the drug quality metrics reporting program (see story).
“However, as the underlying science has evolved,” the whitepaper continues, “the conversation has shifted from quality metrics toward a more holistic approach that integrates metrics with other behaviors and attributes of effective PQSs. Metrics remain an important tool to monitor the overall health of a facility and the FDA’s Quality Metrics Initiative remains an active and vital aspect of QMM program development.”
CDER’s Office of Product Quality has led the formation of an agency-wide, cross-functional team to develop the QMM rating program and launched two pilot programs to support the development of a strategy to rate manufacturing sites. A U.S.-based pilot of finished dosage form manufacturers ended in 2021 and a second pilot of international active pharmaceutical ingredient manufacturers is ending soon.
Additionally, FDA believes that pharmaceutical manufacturers with favorable QMM ratings should enjoy a competitive advantage. “Manufacturers with higher QMM focus on continual improvement and are therefore more likely to embrace advanced manufacturing technologies which can improve the capability and robustness of the industry and lead to an expansion of domestic pharmaceutical manufacturing,” the whitepaper concludes.