United States FDA has a pivotal role in providing guidance for pharmaceutical quality attributes and defining new ways to improve the quality by publishing new regulations for quality enhancement. Quality management maturity is also one of many new guidance that the US FDA has adopted to enable pharma industry to focus on minute quality matters.
While Quality Management System is an important mechanism that establishes quality in Pharma organization by implementing predefined procedure, systems and practices. However, QMS does not specify about how well an organization has applied quality principles in their routine operational procedures, the QMM solves this problem and provide the current level of quality of a particular organization.
It aims to raise awareness in all areas of Pharma processes and devise mechanism to improve quality and reliability
What is quality management maturity?
Quality Management Maturity is defined as the degree to which quality practices and principles have been applied in an organization. In simple words, it is the present state of quality for an organization, and describes the current willingness in fulfilling quality requirements, across various departments
Quality Management Maturity is a step further in implementing quality systems for the pharmaceutical industry. Developed by United States FDA, it focuses on assessing the current quality state and suggesting improvements, where required.
A high degree of maturity means an organization has integrated maximum quality practices in their businesses & manufacturing operations, and is producing high quality products. As a result, the pharma organization is rewarded by increased market share, good reputation and higher rates of acceptability by regulatory bodies , as compared to other pharma organizations.
History
The basis of QMM is the FDA report, "Drug shortages: Root Causes and potential solution'. In this report, the FDA identified various root cause for drug shortage, and one of them was
"The market does not recognize and reward manufacturers for mature quality systems that focuses on continuous improvements and early detection of supply chain issues"
In this report, the FDA suggested "Developing a rating system to recognize drug manufacturers to invest in Quality Management Maturity for their facilities"
After these findings, the FDA started working on it, and in 2021 the FDAs "Center for Drug Evaluation and Research" started an initiative to develop Pharmaceutical quality rating system, and became known as "Quality Management Maturity".
The man advantage of QMM, as proposed by FDA CDER to allow pharma product buyers to differentiate among pool of manufacturers on the basis of quality ratings. As a result pharma organization with higher quality rating is incentivized for establishing quality practices and following risk management frameworks, by increased customer trust, more market share and priority over other pharma manufacturers that have low quality rating.
Advantages
Let's look at some advantages of QMM
Helps prevent drugs shortage
One of the reasons for drugs shortages are quality issues in pharma organization that leads to delay in routine production process, until desired quality attributes have been implemented and quality metrics achieved. Additionally, improper quality practices also result in product recalls, further delaying the drug supply to the market.
Quality Management Maturity uses a rating system for an organization that describes how well an organization is implementing quality principles continuously in their routine operations. Rather than just implementing quality principles, it allows a pharma organization to measure GMP and Quality Principles, and differentiates organization that has lower level of QMM.
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