FDA reopening the submission period for Quality Metrics Feedback Program

FDA reopening the submission period for Quality Metrics Feedback Program

FDA announced in the Federal Register that it is reopening the submission period for the notice entitled “Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program” that originally published on June 29, 2018. The Agency is taking this action to allow interested persons additional time to participate in the program.  To be considered for the program, a company should submit a statement of interest for participation by December 30, 2019.

In June 2018, FDA announced this program to gather feedback on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation. This effort builds on stakeholder comments requesting continued dialogue on quality metrics and provides ways for industry to engage the Agency and inform FDA’s use of quality metrics. 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. The new program provides an opportunity for FDA to continue learning about the advantages and challenges companies have experienced in implementing quality metrics programs.

Participation in this effort is voluntary, and the program is intended to foster the joint efforts of FDA and stakeholders to further understand robust quality metrics programs, which will help FDA, drug manufacturers, and patients. Drug manufacturers will benefit from a better understanding of how quality metrics are a common feature of quality culture, and support improvements in product and process quality.

Companies have asked what topics could be included in feedback meetings.  We encourage including any topic relevant to this outcome and associated case studies to assist in the learning process. Further, a company has the flexibility to include or exclude topics in their meeting request or submission to the pilot program. Example meeting topics include:

(1) which quality metrics are used and why;

(2) definitions of metrics data elements across a company to facilitate comparison of the quality metrics over time and across multiple sites (if applicable);

(3) how the metrics are used by site and corporate management (e.g., initiating continual improvement activities);

(4) current approach to quality culture assessment, improvement, and management.

Understanding the benefits and challenges of existing quality metrics programs will necessarily inform and improve the development of an FDA program. Once the FDA program is implemented, FDA intends to use quality metrics data to further develop the FDA’s risk-based inspection scheduling (e.g., decreased surveillance inspection frequency for certain establishments), to improve the efficiency and effectiveness of establishment inspections, to improve FDA’s evaluation of drug manufacturing and control operations, and to identify situations in which there may be a risk for drug supply disruption.  As this Feedback Program is for learning purposes only, FDA does not intend to draw conclusions from the information shared and these programs are not intended to supplement or replace a regulatory inspection or application assessment.

In December 2018, we published Frequently Asked Questions about the Feedback Program.  Additional questions can be sent to OPQ-OS-QualityMetrics@fda.hhs.gov.