The FDA has taken another step towards realizing their vision for encouraging pharmaceutical quality management practices. FDA’s Center for Drug Evaluation and Research (CDER) has developed a program to promote quality management maturity (QMM) at drug manufacturing facilities. The QMM Assessment Tool evaluates how effectively businesses monitor and manage quality and quality systems. The QMM program’s goal is to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.
As previously reported, adopting mature quality management practices has far reaching consequences. It gives top rated manufacturers a competitive advantage by optimizing manufacturing process performance and product quality, providing more confidence in supply chain reliability, and fostering continual improvement.
QMM versus CGMP
Quality maturity is independent of an organization’s size or age and the types or number of products produced.
QMM assessments are not used to evaluate compliance with CGMP. Compliance with CGMP is carried out by inspection by credentialed investigators. Inspections are mandatory and refusal to permit entry or inspection is prohibited.
In contrast, QMM assessments are NOT part of FDA’s inspection authority; participation in the QMM program is voluntary (although FDA staff may be part of the assessment team). QMM assessments focus on evaluating behaviors, practices, and quality culture within an organization. Higher levels of QMM indicate a higher process capability and performance and a reduced risk of quality failures that can contribute to drug shortages.
QMM assesses manufacturing establishments; QMM does not evaluate product quality.
QMM assessments are also distinct from Quality Metrics. Quality metrics are quantitative data to determine the capability and effectiveness of manufacturing processes and systems. QMM assessments are qualitativeand focus on approach – understanding why organizations select and define specific metrics or monitoring and how they leverage data to drive continuous improvement.
QMM is NOT a requirement, but it is integral to a company’s quality system. Most establishments already have processes and practices aligned with QMM. Improving quality systems can lead to long-term cost savings and other benefits.
QMM Assessment Process and Practice Areas
The QMM Assessment Tool is to be used by a team of assessors using a standardized protocol. Companies participating in the QMM program will receive a pre-interview questionnaire to help frame the discussion during the onsite or hybrid assessment. The use of the questionnaire coupled with the active discussion will provide insights into the organization’s quality management policies and practices and will lead to the development of meaningful recommendations for improvement.
5 practice areas have been identified as key to mature quality management:
- Management Commitment to Quality
- Business Continuity
- Advanced Pharmaceutical Quality System (PQS)
- Technical Excellence
- Employee Engagement and Empowerment
A brief description of each practice area and its importance to QMM:
Management Commitment to Quality
Management is responsible for establishing the organization’s quality policy and objectives, ensuring that these objectives are prioritized, and aligning them with the business objectives and strategic plan. Effective communication is vital to fostering a commitment to quality throughout the organization.
Business Continuity ensures that business operations are sustained during expected and unexpected disruptions while minimizing economic losses. Given the complexity and interdependencies in the pharmaceutical supply chain, it is essential to design operations and supply chains to ensure supply reliability against potential disruptive events
Advanced Pharmaceutical Quality System (PQS)
An advanced Pharmaceutical Quality System effectively uses quality principles and risk management approaches to ensure its continued suitability, capability and reliability to minimize disruptions to drug production.
Building mature systems relies on effectively identifying hazards, analyzing and mitigating risks associated with those hazards, implementing good governance, and establishing robust monitoring programs. A proactive approach to QMM can minimize the occurrence of quality-related failures.
Technical excellence involves effectively managing information and data. Technical excellence also includes implementing innovative manufacturing processes or novel solutions to problems impacting any aspect of the business.
A commitment to technical excellence reflects a culture that proactively enhances the quality of pharmaceutical products, processes and services while providing operational excellence within the organization.
Employee Engagement and Empowerment
Employee engagement relates to employee motivation and commitment to positively impact an organization’s quality policy and quality objectives. Engaged employees understand and care about how their roles within the organization impact product quality and availability.
A culture of active participation can more effectively leverage the expertise, experience and input of employees and drive continual improvement.
The QMM assessment tool provides a structured, objective approach to evaluate an organization’s level of maturity in the five practice areas identified in this article.
Management’s commitment to quality sets the tone for the entire organization. Business continuity ensures operational resiliency, warding off disruptions and minimizing risks to the supply chain. An advanced PQS takes advantage of information and data across products and from all stages of the product life cycle to optimize process performance and product quality. Technical excellence promotes the acquisition of new skills and the implementation of advanced manufacturing and analytical methods to drive operational excellence. Lastly, employee engagement fosters a culture of quality throughout the organization.
It is the goal of the assessment protocol to encourage collaboration between industry and QMM assessors to develop a shared understanding of a commitment to quality.
This represents another step towards encouraging pharmaceutical quality management practices which will ultimately lead to a more reliable drug supply and positive patient outcomes.
To discuss how these FDA initiatives to improve the State of Pharmaceutical Quality impact your organization, please contact firstname.lastname@example.org to schedule an Analyst Inquiry.
To learn more, check out these related articles on Axendia’s website:
- FDA Reports on the State of Pharmaceutical Quality
- FDA to Rate Industry on Quality Management Maturity
- FDA Reports on The State of Pharmaceutical Quality (FY 2020)
- FDA Remote Regulatory Assessments Are Here To Stay
The opinions and analysis expressed in this Briefing Note reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this report is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This report is not intended to endorse any company or product and should not be attributed as such.