Earlier this year, the U.S. Food and Drug Administration (FDA) announced two new voluntary quality programs — the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program. The FDA notes that quality metrics are often used to not only monitor the quality control systems and processes, but also to identify opportunities for manufacturing improvements. Participation in one or both of the programs is voluntary.
In a blog post co-authored by Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, and Michael Kopcha, Director of the Office of Pharmaceutical Quality, they link this effort and the new programs to their work to address drug shortages, saying, “The proximal cause of many drug shortages are quality issues such as substandard manufacturing facilities or processes. Quality metrics can be useful in identifying situations in which a drug supply disruption may occur, which can help mitigate potential future drug shortages. This will help to reassure patients that quality medicines will be available when they need them.”
According to the blog post, the programs were developed to respond to stakeholder and will provide an opportunity for ongoing engagement with the industry to inform the FDA’s use of quality metrics. The officials also intend for the programs to help drug manufacturers gain a better understanding of how quality metrics are a common feature of quality culture, and support improvements in product and process quality.
The Quality Metrics Feedback Program
The Quality Metrics Feedback Program solicits information from drug manufacturers and sponsors that have implemented, and are currently using, quality metrics programs. “Feedback from early adopters, manufacturers who implemented quality metrics programs to address significant manufacturing problems, and independent academic research indicates that manufacturers’ overall quality programs benefit from an establishment’s quality metrics program,” FDA said in a statement.
The FDA is also encouraging applicants eligible for Type C meetings as well as abbreviated new drug application (ANDA) holders to submit meeting requests to the FDA to discuss quality metrics for specific products.
Further, as part of the feedback effort, the FDA is beginning a pilot study to gather feedback from other types of establishments where these types of meetings are not applicable, such as active pharmaceutical ingredient suppliers, over-the-counter monograph product establishments, and contract manufacturing organizations (CMOs).
The Quality Metrics Site Visit Program
This program is designed to provide on-site, firsthand learning opportunities to the FDA staff involved in the development of the FDA Quality Metrics Program. The Site Visit Program also is intended to provide stakeholders with the opportunity to explain the advantages and challenges they’ve experienced when implementing and managing their quality metrics programs.
According to Dr. Woodcock and Dr. Kopcha, these new initiatives continue to enhance the focus of the conversation between the FDA and drug manufacturers to better understand (and make use of) quality metrics programs. They are confident these efforts will improve both the efficiency and the effectiveness of drug manufacturing, helping to assure a reliable and high-quality drug supply.