FDA Quality Metrics Program: An Update For Pharma
Judy Carmody, Ph.D.
Entrepreneur | Operations & Quality Leader | Life Science Executive | Navigator of the Ambiguous | Strategist | Tactician
June 9th, 2022 marked the deadline for pharma to offer feedback on the US Food and Drug Administration (FDA)’s pared-down plan to collect Quality Metrics data. Quality Metrics help the drug and biological product industry to monitor quality control systems and processes and drive continuous improvement efforts in manufacturing.
Whether you in-source or outsource most or all of drug manufacturing activities, a first step towards accelerating time to market and building quality into the product is obtaining an objective means of measuring, evaluating, and monitoring the product and process life cycle to proactively identify and mitigate quality risks – i.e., Quality Metrics.
Such an approach is a positive first step to bring potentially life-saving therapeutics to the market. With this idea in mind, the FDA is attempting to revise and renew its earlier effort to obtain manufacturing quality data so that the agency can work to alleviate potential drug shortages and promote enhanced quality management.
Without Quality Metrics, it can be challenging to manage operations at higher levels of safety, efficacy, and delivery. It also makes performance improvements near impossible to implement.
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Bottom line? “You can’t manage what you can’t measure.” Quality Metrics are important in order to update and innovate manufacturing practices and improve operational reliability (i.e., state of control). Failure to innovate can lead to quality problems that have a negative impact on public health. Furthermore, sustainable cGMP compliance is difficult to achieve without a focus on continual improvement.
This program is a great initiative and a long time coming. Why? These data assist the Agency and all parties in developing compliance and inspection policies and practices to improve the ability to predict, and therefore mitigate, future drug shortages. They can also encourage the pharmaceutical industry to implement innovative quality management systems for manufacturing to protect patients.
The challenge will be to build the desire within organizations to “voluntarily” participate in the program. More challenging will be to reach and involve organizations at a much lower level of Quality Management Maturity (QMM) to not only participate, but also have the knowledge, means, ability and resources to participate.
What are your thoughts about the Quality Metrics initiative, QMM and what the FDA is attempting to do? Can it work? What do you see as possible headwinds? Can they be overcome?
Former Vice President @ Zuellig Pharma | Quality Assurance, HSSE
2 年Its a great piece Judy. Quality metrics remain incredibly important to effectively managing Quality Risk, not just in manufacturing, but throughout the Supply Chain. As Harsh touched on above, one key is in the automation of data collection and the other is quality of data itself. MES has an important role to play here. The concern may be in the transparency of what results are produced but this should also be viewed as the opportunity to address underperformed or risk identified, and reduce that risk now and for the future.
CEO @ Qualtivate | QA, CSV and GxP Compliance Consultant | Expertise in implementing systems in quality, IT/OT, regulatory affairs, manufacturing, lab informatics, clinical ops, supply chain, ERP, AI/ML and more
2 年Life science companies that automate data collection, analysis, and visualization for its quality management reviews to imporve compliance and accelerate cross-functional decision making will have an edge. With the advancements in no-code tools, AI /ML and other technologies; companies have the opportunity to redesign their quality management and reporting to capture metrics in real-time and improve the efficiency of the quality system as a whole.