What is Quality Management Maturity (QMM) and how is it Impacting Life Science?
The FDA’s Center for Drug Evaluation and Research (CDER) established QMM with unanimous approval from The Pharmaceutical Science and Clinical Pharmacology Advisory Committee in November 2022. This program aims to actively encourage drug manufacturers to elevate their facility performance by implementing consistent, reliable, and robust business processes while prioritising continuous improvement. For a deeper understanding, the FDA released a whitepaper in August 2023.
Regulators increasingly demand that life science companies adopt QMM programs, with industry giants like Pfizer and Novartis already embracing this transformation. But how do these programs stand out from their predecessors, and what advantages come with this transition?
How it Differs
Quality Management Maturity distinguishes itself from current QA processes in several significant ways:
1. Focus: While current QA processes often narrow down to specific activities like testing and inspection, QMM centers on enhancing the overall quality management system.
2. Scope: QMM casts a wider net compared to conventional QA processes. It encompasses all facets of the quality management system, spanning process design, risk management, and continuous improvement.
3. Approach: Unlike reactive processes currently in place, QMM takes a proactive stance on quality. QMM programs prioritise defect prevention, rather than detection and correction after productivity has already suffered.
4. Continual Improvement: QMM programs are designed around continuous improvement. They facilitate ongoing enhancements to the quality management system.
Moreover, QMM stands out as a more data-driven approach than current QA processes. It leverages data to pinpoint areas for improvement and monitor progress over time.
In summary, QMM represents a comprehensive and proactive approach to quality management, offering life science companies the potential to elevate product quality, reduce costs, bolster compliance, and enhance their reputation.
Embarking on the QMM Journey
To embrace Quality Management Maturity (QMM), a life science business can embark on the following steps:
- Assess Current Quality Management: Evaluate the existing state of quality management through either self-assessment or by engaging a consultant to perform an assessment.
- Identify Improvement Opportunities: Based on the assessment, pinpoint areas within the quality management system that require enhancement.
- Craft a QMM Plan: Develop a detailed QMM plan outlining specific, measurable, achievable, relevant, and time-bound steps for improving the quality management system.
- Execute the QMM Plan: Implement the QMM plan in phases. Initiate with a select few key areas and gradually expand the program’s scope.
- Monitor Progress and Adjustments: Continuously monitor progress and be prepared to make adjustments to the QMM plan as required. This involves regular audits and reviewing quality performance data.
Undoubtedly, embracing QMM presents its challenges, but it’s a worthwhile investment. If you’re considering this transformative journey and require the right expertise to navigate it successfully, don’t hesitate to consult with one of our experts. They can guide you on this path towards improved quality management and better business outcomes.