The FDA is taking another step towards realizing the vision for pharmaceutical quality in the 21st century.
To increase transparency and incentivize investment in mature quality management practices, the Center for Drug Evaluation and Research (CDER) is developing a framework to objectively rate the Quality Management Maturity of pharmaceutical manufacturing sites.
According to the FDA: Quality Management Maturity (QMM) is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.
CURRENT STATE: Product Quality is High, Supply Chain Resilience is Low, Drug Shortages Persist
Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. It is achieved by assuring that medical products are fit for their intended use and comply with Current Good Manufacturing Practice (cGMP) requirements. However, as we have noted in the past Compliance does not equal Quality (see Quality: STOP Working on Compliance ).
Adherence to cGMP standards also does not indicate that a manufacturer is investing in improvements or developing process controls to prevent supply disruptions. Just-In-Time and Lean Manufacturing principals envision a ‘perfect’ world that do not factor in Black Swan events
The Federal Drug Shortages Task Force reported in 2019 that over 60% of drug shortages between 2013 and 2017 were associated with manufacturing or product quality problems. It was determined that one of the root causes of these drug shortages was the fact that the market does not recognize and reward manufacturers for having mature quality management systems.
DESIRED STATE: Dependable, decisive, and dynamic business processes to achieve quality objectives and promote continual improvement.
Determining if a company has achieved QMM status is partially based on how fully and completely the concepts of ICH Q10 have been implemented. A transparent rating system could inform buyers of the level of QMM status of the vendor. The implementation of such a rating system is challenging. However, not having such a tool risks the likelihood of problems with supply chain continuing to persist.
In a very competitive market, there has been a push for continual improvement in innovation. However there has been little incentive for businesses to continually improve the managing of process or quality systems. Although FDA investigators look for deficiencies in meeting cGMP, there is no measure to determine how far a site’s pharmaceutical quality system (PQS) rises above the minimum requirements. The ICH Q10 Pharmaceutical Quality System expands cGMP with the concept of an effective PQS but at this time there is no rating system to inform purchasers about the level of QMM of suppliers.
Without a direct reward to manufacturers to actively invest in changing their processes, shortages cannot be avoided, especially for generic drugs. Adopting quantitative measures of quality has been successful in the automotive and aerospace industries. Unfortunately, some pharmaceutical firms do not see the long-term value of mature quality systems.
Implementing transparent QMM ratings could help manufacturers identify ways to improve the effectiveness of their PQS, take advantage of regulatory flexibilities described in ICH Q10, and help move the pharmaceutical industry toward the six-sigma quality common in other industries.
CONSIDERATIONS FOR A QMM RATING SYSTEM
Key elements of a QMM rating program include:
- Quality culture must be foundational for mature quality management.
- A QMM assessment tool must be objective and consistent across manufacturing sites and agnostic to the product or size of operations
- A standardized QMM assessment tool must be validated
- There must be clear incentives for industry to achieve higher QMM.
- Transparency is critical in establishing a QMM rating system.
FDA NEXT STEPS
Over the past several years the FDA has been moving away from compliance-based oversight to a performance based regulatory practice (see Quality Metrics Support Improved Quality Across the Value Network). QMM ratings are part of that evolution. The sharing of information, data and ratings in a public forum is uncomfortable for many industry executives. However, this transparency is a necessary driver for industry improvement. Public knowledge of facility issues and product recalls already is known to negatively affect stock prices; a poor QMM rating could be just as costly.
Conversely, good QMM ratings may encounter less share volatility. Stakeholders in other industries initially protested the use of metrics and ratings, but there is now a general acceptance and recognition of their role in driving quality (e.g. Medicare quality ratings).
The FDA needs to continue to include all stakeholders during and after the development of the QMM ratings to ensure all issues are addressed. Conducting public workshops to receive feedback and holding advisory committee meetings are necessary to ensure industry buy-in and compliance.
The long-term effects of an FDA QMM program could be far-reaching: Top rated manufacturers (of all sizes) would have a competitive advantage enabling them to grow their market share and their workforce. Manufacturers with higher QMM tend to focus on continual improvement of all facets of their business and therefore are more likely to embrace new manufacturing technologies which can improve the capability of the industry and lead to expansion of domestic pharmaceutical manufacturing.
The potential benefits for stakeholders are more direct: manufacturers with higher QMM get recognition in the market; purchasers and payers get more insight and confidence in the supply chain of the drugs or components they buy or reimburse; and patients, pharmacies and health care professionals get higher quality medicine with less risk of supply shortages.
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