All drug and medical device manufacturers require quality management systems for regulatory compliance. However, no guidelines specify what a mature and robust quality management system looks like. Until now.
The FDA steering committee approved a quality management maturity system in 2022 and is set to launch in 2023 formally.
What is Quality Management Maturity?
Quality Management Maturity is the "…stage attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objective and promote continual improvement", FDA writes.
Quality Management Maturity is introduced by the Center for Drug Evaluation and Research (CDER) to help facilitate the vision of the CDER to ensure a "maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive oversight."
Why is Quality Management Maturity needed?
For the past decades, there have been disruptions in drug supplies in the US, leading to drug shortages. Especially during the COVID-19 public health emergency, supply chains became vulnerable, and it became apparent that something needed to be done about global and US drug shortages.
A 2020 multi-agency federal report investigated the root causes of the drug shortages and found that one of the three leading causes was a failure to recognize and reward drug manufacturers for mature quality management systems. Without an incentive to aim higher with their quality management systems, manufacturers were likelier to consider mainly cost factors and comply with only the minimum requirements of Good Manufacturing Practices (cGMPs).
The CDER proposed a rating system to keep manufacturers, regulators, and other economic operators informed of the performance and strength of quality management systems. Besides informing other manufacturers, the rating system should increase patients' confidence in the availability of drugs. The rating system should also support manufacturers making post-approval drug changes with more flexibility and less regulatory oversight.
A multi-center working group has been established to develop the Quality Management Maturity rating program with operators from the FDA, the pharmaceutical industry, and other stakeholders.
Why is Quality Management Maturity important?
Quality management maturity is destined to improve the state of affairs for various economic operators in the pharmaceutical industry. It has been demonstrated by multiple years of research that advanced quality management system practices increase the effectiveness and efficiency of pharmaceutical delivery performance, along with operational stability.
Patients and users
If the pharmaceutical industry continues to improve its manufacturing processes and quality management systems, patients will automatically gain more reliable access to high-quality drugs. By helping quality management systems mature and rewarding manufacturers for it, we should see fewer quality-related drug shortages and fewer drug recalls. Likewise, costs will be decreased, while patient satisfaction is destined to increase.
Buyers
Buyers looking to purchase drugs will benefit from a transparent rating system, informing them of the quality management practices of the manufacturer. To ensure price is not the only key market driver, buyers can actively make choices based on prospective manufacturers' quality management maturity rating instead of only on cost.
Industry
With transparent quality management maturity ratings, manufacturers will obtain immediate feedback on the effectiveness of their quality management system, driving improvement and quality.
FDA
Lastly, with the implementation of a rating system, the FDA will be quickly informed about the quality management practices of manufacturers, which will provide valuable insights into product and facility qualities. The additional data on the maturity of quality management systems will help inform risk-based decision-making across the entire industry. Furthermore, if the FDA gains confidence with a manufacturer due to the high quality and maturity of their quality management system, they might offer them a higher degree of regulatory flexibility, including during post-approval product and regulatory changes.
How can drug manufacturers implement quality management maturity?
Participation in the quality management maturity rating system is optional. However, for any drug manufacturer wanting to participate in the program, there are four steps recommended for QMM implementation:
- The basic requirements for drug products and sustainable compliance, as described in 21 CFR 210/211 and ICH Q7, should be followed.
- Any quality management system should be implemented according to ICH Q10.
- Do a detailed gap analysis to assess the maturity level of the quality system and all subsequent processes and identify the system's strengths and weaknesses.
- Once gaps have been identified, a plan can be developed to improve the quality management maturity towards the optimized stage 5 (see below).
How will the quality management maturity rating system work?
The QMM rating system has not yet been defined and launched. However, in the preliminary pilot investigations a scoring approach was used to determine the level of maturity on a scale of 1-5. Scores were assigned for each area and aggregated to reach a final score per manufacturing establishment.
While this is not the final system, it can be assumed that something similar will be implemented.
Some of the challenges with the rating system includes subjectivity during rating sessions, redundant topics within or between practice areas, and complexity of the rating rubric. The FDA will need to develop objective criteria and account for missing and outlier data when defining their final QMM rating system. Likewise, assessors will need to be trained in systematic processes and interview techniques, as well as standardizing procedures as much as possible.
Differences between quality management maturity and quality metrics
Quality management maturity sounds suspiciously like quality metrics. However, quality management maturity is a holistic and more qualitative approach compared to the quantitative measures of quality metrics.
Furthermore, quality metrics are mandatory under FDA regulations, whereas quality maturity management is entirely voluntary.
Quality metrics are a key aspect of quality management maturity.
