Would you like to be ahead of the curve on CDER’s compliance initiatives? Read this summary ProQuality completed on the recently released QMM Program.
In 2023, the FDA's Center for Drug Evaluation and Research (CDER) introduced the Quality Management Maturity (QMM) program to boost quality management practices in drug manufacturing establishments. This initiative intends to create a QMM Assessment Tool, through a protocol designed to evaluate quality management practices effectively. The QMM program aims to instill a culture of quality throughout the industry, going beyond current good manufacturing practice (CGMP) requirements.
The QMM program's primary aim is to strengthen quality culture in the pharmaceutical industry, emphasizing a commitment to quality at all organizational levels. It also acknowledges and rewards establishments with advanced quality management and identifies areas for improvement, promoting growth and operational efficiency. Additionally, it encourages the adoption of mature quality management to minimize quality-related risks and ensure a dependable pharmaceutical product supply.
Quality issues caused 62% of drug supply disruptions between 2013 and 2017. The QMM program addresses this by acknowledging manufacturers with mature quality management systems. The QMM assessment focuses on quality culture, quality practices, and risk management to create a collaborative environment for identifying strengths and opportunities.
The process would start by obtaining an accurate understanding of the establishment's QMM, a pre-interview questionnaire, and interactive discussions. This process supports the enhancement of quality practices and a strong quality culture within the establishment by providing meaningful recommendations for improvement.
A review is performed to assess how the establishment develops and implements a risk management plan to address potential supply disruptions. It is also assessed how the company utilizes information from various product lifecycle stages and other data, such as customer feedback, to enhance quality practices.
The direct engagement with the establishment as part of the assessment typically takes two to five business days.
After each assessment, participants receive a report outlining areas for improvement, potentially providing a benchmark comparison against similar facilities.
The assessment protocol covers five practice areas identified through a comprehensive review process including real-life examples involving the creation and execution of ICH Q9(R1), ICH Q10, and ICH Q12, along with industry standards like the ISO 9000 Series of Standards.
1. Management Commitment to Quality: This area emphasizes the critical role of leadership in setting the tone for a culture of quality. Effective management prioritizes quality goals, ensures their alignment with business objectives, and allocates resources appropriately. Communication is essential in fostering a commitment to quality.
2. Business Continuity: This practice area focuses on ensuring that business operations continue during both expected and unexpected disruptions, safeguarding a reliable supply of drug products. Establishments must understand and mitigate risks in their supply chains to minimize disruptions.
3. Advanced Pharmaceutical Quality System (PQS): An advanced PQS employs quality principles and risk management to ensure the continuous suitability, capability, and reliability of drug manufacturing operations. It is essential for efficient production, product quality, and supply chain reliability.
4. Technical Excellence: Technical excellence involves effective data management and the adoption of innovative technologies and methods. This practice area encourages establishments to use data to improve their processes and product quality.
5. Employee Engagement and Empowerment: Engaged employees actively participate in improving quality practices. This practice area focuses on fostering a culture where employees understand the impact of their roles on product quality and are empowered to make suggestions and drive continual improvement.
Each area addresses specific aspects of quality management within the establishment.
Although the FDA indicates that QMM assessments are not assessments of CGMP compliance, a strong QMM indirectly reflects CGMP compliance. These assessments although not meant to judge product quality or CGMP compliance; they focus on how well an establishment's behaviors, practices, and quality culture are performing. Higher QMM levels indicate better process capability and performance, reducing the risk of quality issues that could cause drug shortages.
It's important to note that QMM assessments are focused on evaluating manufacturing establishments, not product quality. Maturity in this context is unrelated to factors like establishment size, age, or the types and quantity of products produced.
QMM assessments and Quality Metrics (QM) serve distinct purposes. Quality Metrics involve numerical data to assess manufacturing process and system effectiveness, while QMM assessments delve into methods and approaches establishments use. They examine why specific metrics are chosen for monitoring and how data is utilized for continuous improvement.
In essence, QMM is not an extra burden or a new requirement. It's an integral part of an establishment's quality system. Many establishments already have processes aligned with QMM, and actively striving for continuous improvement naturally enhances their QMM.
Promoting a culture of quality doesn't require creating new departments; it should seamlessly integrate with the existing quality system. Furthermore, the benefits of improving quality systems are widely recognized and can lead to long-term cost savings. Establishment should focus on the return on investment, not just the initial cost required to establish QMM.
The QMM program enhances quality management, by focusing on critical practice areas, it promotes a culture of quality, minimizes disruptions, and improves patient outcomes. Technical expertise encourages the development of new capabilities and the utilization of cutting-edge manufacturing and analytical methods tailored for specific purposes, thereby promoting operational excellence. If you need more information or want to be ahead of the curve, contact ProQuality Network for guidance.
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