New developments in the FDA's Quality Management Maturity Program

On November 2-3, 2022, the FDA hosted a two-day Advisory Committee Meeting on Pharmaceutical Science and Clinical Pharmacology
.
The conference focused on two key themes related to the Office of Drug Quality (OPQ) mission to promote access to quality medicines for the American public: Quality Management Maturity (QMM) and KASA
.
This article will introduce the main topics
discussed about QMM.

On November 2, the committee discussed the Center for Pharmaceutical Evaluation and Research (CDER) Quality Management Maturity (QMM) program
.
QMM is the state
achieved when pharmaceutical manufacturers have consistent, reliable, and robust business processes in place to achieve quality objectives and promote continuous improvement.
CDER It is proposed to develop a rating system to help incentivize pharmaceutical manufacturers to adopt more mature quality management practices
in their facilities.
The committee will consider the impact of
the QMM program on the pharmaceutical industry, drug shortages and supply chain resilience.
FDA will seek comments to determine whether experts from academia and industry support it Development of the CDER QMM program to incentivize investment in
proven quality management practices.

The meeting began with the topic of drug shortages, pointing out that one of the main reasons for drug shortages is quality problems, and the root cause of quality problems is that the market does not recognize and reward manufacturers with "mature quality systems" that focus on continuous improvement and early detection of supply chain problems, so it is recommended to develop a rating system to incentivize pharmaceutical manufacturers to invest in QMM.

The second topic of the conference was the future of
pharmaceutical quality.
Drug quality is to ensure that every dose is safe and effective, free of contamination and defects
.
This gives patients confidence
in their next dose.
Drug quality includes three aspects
: product quality, process quality and quality management.
The key to ensuring the quality of medicines is transparency
.
The White House 100-Day Report is again quoted here: FDA should lead the development of a framework to measure and provide transparency about the maturity of facility quality management, engaging with industry, academia, and other stakeholders
.

After introducing the two major topics of drug shortage and drug quality, the introduction
of quality management maturity begins.
The FDA says the QMM program's push relies on an existing scientific research base
.
It is worth mentioning that in these four academic studies, in addition to PDA and the quality culture of the University of St.
Gallen, the FDA placed at the top of the slide is titled "Quantitative" by Peking University published by the Journal of Drug Innovation Analysis of the QMS for Pharmaceutical Manufacturing (Quantitative Analysis of Quality Management Systems for Pharmaceutical Manufacturing)", which for the first time proposes a set of quality management systems (QMS) for pharmaceutical manufacturing based on empirical data from Chinese pharmaceutical companies Statistical methods
for performing quantitative analysis.

The FDA emphasized that the realization of QMM needs to be supported by regulatory innovation data, and proposed for the first time that the data is divided into lagging indicators and leading indicators indicators), and these two concepts are also quoted by the FDA from the Peking University research article mentioned above (through data analysis, finding the leading indicators of the quality management system is the main conclusion of the article).

Lagging indicators recommended by FDA include: quality defect reporting, drug sampling and testing results, external data, application data, inspection data; Leading indicators include: Quality Management Maturity Rating, Quality Metrics
.
Highlight that regulators are unable to address many of the problems
with lagging indicators.
True innovation requires new data and science-based leading metrics
.
Through the data analysis of lagging indicators, enterprises should find correlations with leading indicators, so as to rectify specific indicators and ultimately achieve the goal
of quality management maturity.

The FDA then discussed several topics: lessons learned from FDA's QMM program, stakeholder perspectives, FDA's vision for QMM, stakeholders, and the potential benefits of FDA, all of which were discussed in the Quality Management Maturity White Paper released in April and the Quality Management Maturity Webinar in May.

The FDA had stakeholders vote on several key issues at the QMM webinar in May, and the results
of the vote on several issues were announced at this meeting.

About the QMM Program: