Agency looks to modernize drug quality programs with voluntary quality metrics programs.
The FDA hopes that two new voluntary initiatives will help increase the safety of drug products. The programs are based on the concept of quality metrics, which are widely used in many other industries to evaluate the performance of quality control/management systems and processes.
Quality problems are one of the main sources of drug shortages, and the agency believes that quality metrics can be used to identify issues earlier and thus prevent supply disruptions. FDA also believes that quality metric data will help the agency conduct more effective better risk assessments for inspection scheduling and could potentially decrease the inspection frequency for lower-risk facilities.
The Quality Metrics Feedback Program and the Quality Metrics Site Visit Program were developed in response to “stakeholder requests for continued dialogue on quality metrics” and as a way to provide drug makers with a mechanism for providing FDA on ideas for using quality metrics in the future. They are designed to help manufacturers gain a better understanding of the role quality metrics play in an effective quality culture.
The Quality Metrics Feedback Program provides drug manufacturers and sponsors with quality metrics programs already in place, a mechanism for providing data to FDA. The agency is “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.” A pilot study is also being initiated to gather feedback from other facilities for which these types of meetings are not applicable, including active pharmaceutical ingredient suppliers, over-the-counter monograph product establishments, and contract manufacturing organizations.
Through the Quality Metrics Site Visit Program, FDA will provide on-site, firsthand learning opportunities to agency staff involved in the development of the FDA Quality Metrics Program. Simultaneously, stakeholders will have the opportunity to explain the advantages and challenges they’ve experienced when implementing and managing their quality metrics programs.