FDA Announces Two Initiatives to Inform Quality Metrics Program Development

FDA is announcing two new programs to gather feedback on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation. These efforts, the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program, build on stakeholder comments requesting continued dialogue on quality metrics, and provide 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 programs provide an opportunity for FDA to continue learning about the advantages and challenges companies have experienced in implementing quality metrics programs.

As part of the Quality Metrics Feedback Program:

• FDA is encouraging new drug application holders to request Type C Formal Meetings and abbreviated new drug application (ANDA) holders to submit pre-ANDA meeting requests to FDA to initiate discussions on quality metrics for specific products.

• FDA is also initiating a pilot study to gain feedback from other types of establishments, including active pharmaceutical ingredients (API) establishments, contract manufacturing organizations (CMOs), over-the-counter (OTC) monograph products establishments, or marketed unapproved finished drug products establishments.

The Quality Metrics Site Visit Program:

• This voluntary site visit program is designed to offer experiential and firsthand learning opportunities to FDA staff involved in development of FDA’s Quality Metrics Program. 

• Staff will gain exposure to robust quality metrics programs through on-site visits, tours of operations, and discussions with establishments to assist staff in further developing FDA’s Quality Metrics Program.  FDA staff will also observe how quality metrics data are gathered, collected, and reported to management. 

Participation in either of these efforts is voluntary, and the programs are 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. Understanding the benefits and challenges of existing quality metrics programs will necessarily inform and improve the development of an FDA program. 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.