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Program looks to establish framework for agency and purchasers to “objectively rate” manufacturing sites.
To further encourage pharmaceutical companies to invest in the reliable production of higher quality products, FDA is reviving efforts to establish a quality management maturity (QMM) program. An updated version of this approach is spelled out in a new white paper from the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) and will be addressed further at two workshops in May.1
QMM encourages drug and biotech firms to develop manufacturing systems and measures that indicate the quality performance of production and marketing systems in ways to avoid drug shortages. The program aims to reward companies that achieve certain standards by supporting premium prices from drug purchasers and other stakeholders for medical products from manufacturers with high QMM measures ensure reliable, high quality supplies. Thus, “good actors” in the pharmaceutical industry that earn high quality ratings from public health programs would gain a competitive advantage in the market.
This announcement comes on the heels of FDA’s renewed effort to update its drug quality metrics program, as recently reported in Applied Clinical Trials. The QMM program aims to establish a flexible approach for manufacturers to report on a range of quality measures for facilities, operations and products.
QMM is “Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals,” the report headlines, and can be achieved through a framework for FDA and purchasers to “objectively rate” manufacturing sites.2 The initiative sets a framework for how companies can collect information for assessing and rating manufacturing sites on their quality operations. CDER will define the scope and meaning of QMM scores with an aim to establishing objective, consistent, and validated assessment tools across manufacturing sites. This latest proposal builds on two pilot programs that engaged manufacturers in the process for developing QMM criteria at domestic and foreign sites. A takeaway message from participating firms is the importance of minimizing the burden on sites from the QMM process.
The development of a valid QMM rating program fits current efforts by the Biden administration and members of Congress to encourage more drug production in the US as one way to address pharmaceutical industry supply chain vulnerabilities. For healthcare systems to pay more for U.S.-made medical products, manufacturers should be able to demonstrate their higher value and to provide greater assurance of reliability in supply. Quality ratings would be available to the public as a way to drive manufacturer participation and improvement and to encourage the market to reward investment in reliable operations.
These issues will be discussed at FDA workshops on May 24-25. The program will address the potential for QMM to improve supply chain purchasing decisions, its relation to international quality standards and advanced manufacturing operations, as well as FDA quality rating systems for medical devices and other industries.3