News on FDA’s Quality Management Maturity Program-Maturity to Continually Improve and to not be Reactive

March 2, 2023By Holly N. Brevig, Senior Regulatory Device and Biologics Expert

In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system.  The lessons learned were also discussed during a November 2022 workshop hosted by the FDA.  The purpose of these two pilot programs was initially to inform development of a FDA rating system to characterize the QMM of a facility.  FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs.

Before discussing the 2023 paper, it’s important to know that the QMM Program is separate from the Quality Metrics Program, which we previously blogged about here, here, and here.  QMM is an umbrella program that includes quality metrics as well as quality culture, risk management, continual improvement, etc.  FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).  The QMM rating is based on an evaluation of a facility’s quality practices and it is meant to be a leading indicator for detecting problems before they occur, such as a drug shortage.  By way of background, FDA first proposed using a QMM rating in its 2019 Report on Drug Shortages and Potential Solutions.  In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues.  The report recommends using a QMM rating that is shared throughout the market (purchasers, consumers, competing manufacturers) to provide manufacturers committed to QMM with a competitive advantage.  FDA intends to provide regulatory incentives to manufacturers with robust QMM systems, such as reduced inspection frequency and increased regulatory flexibility in making post-approval changes.  FDA proposed using QMM ratings as part of its decision in selecting sites for surveillance and preapproval inspections.

On November 2, 2022, the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee held a meeting on CDER’s QMM Program.  In addition to providing some background on QMM, the FDA presented lessons learned from the QMM Program Pilots.  During the workshop, FDA stated that the QMM Pilot Programs will be used to develop a suitable assessment tool to identify indicators of mature quality systems to build a framework to evaluate QMM best practices and identify areas for continual improvement.  Development of this framework to measure a facility’s QMM was included in the July 2021 White House’s 100 Day Report.

The QMM Pilot Programs were conducted using two contractors who developed the QMM assessment protocol questions and the scoring system.  The contractors also conducted the QMM assessment of seven domestic manufacturers of finished dosage form and eight foreign manufacturers of active pharmaceutical ingredient.  FDA staff served as pilot program observers, but also met with the contractors to provide feedback.  The paper discusses lessons learned about the QMM assessment process, scoring approach, assessor behaviors, and perceptions of the assessment questions, reports, and ratings.  A brief discussion on the scoring approach is provided below.

FDA’s 2022 presentation and the information in the FDA’s 2023 paper on the QMM Pilot Programs are similar, but the paper provides more detail on what general aspects were assessed (referred to as practice areas) and the topics within those practice areas.  For example, domestic establishments that manufacture finished dosage forms were evaluated for the following practice areas: 1) leadership and governance, 2) continual improvement, 3) stakeholder engagement and satisfaction, 4) knowledge management, 5) workforce engagement, and 6) operations.  Topics within the practice areas were assigned scores between 1 and 5 with one representing the lowest quality maturity level and five the highest quality maturity level.  FDA provided teasers in Figure 2, showing that topics under leadership and governance may include management commitment, management reviews, oversight, and monitoring, business excellence and societal contribution, and topics under continual improvement may include customer/patient focus and stakeholder feedback and engagement.  The paper did not provide any detail into how the practice areas and topics were developed, but FDA referenced a number of organizations involved in researching and developing measures of QMM, including the University of St. Gallen and the Parenteral Drug Association (PDA).  A recent 2022 study funded by the FDA was intended to study how QMM characterizes quality and may include potential practice areas and topics for future QMM rating development.  Figure 2 of the 2023 paper showed facility and assessor scores, but it did not describe how assessors and the facilities determined the scores.  There also was not a lot of discussion on how often the scores between the assessors and the facilities aligned or not and what this meant, if anything.  FDA recognized in the paper that multiple assessors may be needed per assessment to minimize bias and to maximize inter-rater reliability.

We will continue to monitor the QMM program’s development and will post further information as it becomes available.