The FDA’s recent decision to undertake the next iteration of the Quality Management Maturity (QMM) Protocol Evaluation Program (2025) by building upon insights gained from past pilots indicates that the QMM initiative is steadily evolving toward formalization. Pharmaceutical manufacturers who undertake preparatory steps now will be best poised to reap competitive advantages after they enroll in the FDA QMM Program when it becomes fully operational. This article continues a series of publications relating to the FDA’s QMM initiative^1,2,3 and shares practical insights for C-suite decision-makers from a recent QMM readiness review at a global pharma manufacturer.

The quality mandate

Enrolling in FDA’s QMM Program is a strategic decision to demonstrate commitment to continuous product quality and process improvement, but readiness and continued vigilance are essential.

The concept to develop an FDA program to rate quality management maturity at drug manufacturing establishments, first proposed by the Interagency Drug Shortage Task Force in 2019, was aimed at incentivizing pharma organizations to adopt more mature quality practices that go beyond compliance. The FDA began building a program that has evolved over the past five years through multiple pilots. The agency’s QMM program is currently under development.

The 2024 voluntary QMM Prototype Assessment Protocol Evaluation Program assessed and scored a drug manufacturing establishment’s level of maturity using a protocol that evaluated five key practice areas:

• Management commitment to quality
• Business continuity
• Technical excellence
• Advanced pharmaceutical quality systems
• Employee empowerment and engagement

A QMM assessment does not evaluate a drug manufacturing establishment’s compliance with current good manufacturing practice (GMP) regulations or statutory requirements. The voluntary QMM Prototype Assessment Protocol Evaluation Program considers establishments with an inspection classification of ‘No Action Indicated’ or ‘Voluntary Action Indicated’ to participate in an assessment. QMM scores are site-specific and cannot be extrapolated to other sites within a company or group. QMM scores may eventually be considered in commercial procurement decisions by wholesalers, global purchasing organizations, and hospitals and may even be used by product license holders to select their contract development manufacturing organizations (CDMOs). Further, the FDA may incentivize the industry by providing potential regulatory flexibility to a site with a high QMM score, such as reduced inspection frequency or expedited reviews of product submissions.

Once the QMM Program is launched, higher QMM scores may play a role in attracting and retaining customers, especially in highly competitive markets. Early adoption of FDA’s QMM Program could, therefore, provide an advantage over competitors in both regulatory and commercial spheres. However, to become an establishment that successfully achieves higher QMM scores (i.e., demonstrates higher levels of maturity) at the initial assessment will require companies to prioritize which site(s) to get assessed first, and to review the readiness of site personnel and processes to be scrutinized by the FDA QMM team. In addition, sustaining higher QMM scores in the future or aspiring to be rated as such would also require a comprehensive corporate strategy to exercise continued vigilance by way of commitment to undertake continuous improvement in people, processes, and technology.

Key learnings so far

​Current FDA efforts build upon insight gained from past QMM pilots, industry comments, and stakeholder feedback.

The FDA launched two pilot programs³ (2020-2022) to gain insight from third-party assessments of a facility's quality management maturity to inform the FDA for future development of a QMM rating system. Since the original pilot programs, the agency has continued to explore QMM, evaluating nine additional drug manufacturing establishments through their QMM Prototype Assessment Protocol Evaluation Program in 2024. The FDA announced the continuation of that program earlier this year.

We supported the Foreign Active Pharmaceutical Ingredient (API) Manufacturers Pilot (2020-2022),^4,5,6 in which we developed a QMM Assessment Protocol (see Figure 1 below) and a standardized scoring system. The rubric consisted of a set of evaluation queries, covering topics that go beyond the scope of traditional compliance-based audits, such as operational excellence, supply chain resilience, manufacturing contingency planning, employee recruitment, and quality culture.

Although the pharma industry has not yet achieved consensus on the value of QMM assessments as observed per the 2023 FDA Public Docket Request for Comments, those who participated in the 2020-2022 FDA pilot noted that QMM assessments provided a comprehensive understanding of site operations and identified opportunities for improvement not previously considered by site management.⁷

FDA continues to solicit industry comments on the QMM program through Federal Register announcements and discussions with a range of trade associations, academic, and other private/public sector stakeholders to inform development of FDA’s QMM program. These outreach efforts will assist the agency in efforts to fine-tune the QMM protocols, identify incentives for the industry to participate, and develop scalable program implementation processes.

Proactive planning is key to improving readiness for initial and sustained participation in the program: Selected practical lessons for pharma executives to consider.

Leveraging experience gained from the FDA QMM Foreign API Manufacturer Pilot, we recently independently performed a multi-site QMM Readiness Assessment for a multi-billion-dollar global pharma manufacturer and top-ranked prescription provider to the US market. We provided detailed recommendations for each participating site, including cross-site benchmarking and highlighted key factors for the global corporate team to consider in their QMM journey. This experience generated valuable lessons for API and drug manufacturers planning to participate in future FDA QMM assessments.

As a first step, drug manufacturers should prioritize and shortlist those site(s) that qualify for the FDA QMM program, undertake QMM readiness assessments, conduct cross-site benchmarking, and decide which site(s) may be best poised to participate in the QMM program when FDA starts accepting applicants. By doing so, firms can address potential adverse ratings in advance and avoid negative impacts prior to enrolling in the FDA QMM program, such as diminished reputation and weakened financial prospects.

Prior to participating in the FDA QMM program, firms should also strategize how to implement and monitor continuous improvement activities to become ready for potential QMM re-evaluation by the FDA following initial assessment at a site. Additionally, if resources permit, developing an in-house QMM center of excellence would be a strategic investment by corporate to sustain QMM-related activities that may involve both remediation and continuous improvement.

Next steps

Achieving FDA QMM assessment readiness may require a combination of short, medium-term, and multi-year efforts with corporate executive leadership support to assure success.

Our experience conducting the FDA QMM pilot and subsequent QMM assessments revealed that most organizations were not prepared for a QMM assessment to the same extent they were ready for regulatory compliance audits and inspections. This is unsurprising as many of the covered topics are outside the scope of traditional compliance audits, which industry is accustomed to. To aid pharma manufacturers in understanding the scope of QMM, the FDA has published a white paper⁸ describing their QMM approach and the five practice areas at a high level. Further details may be forthcoming once the QMM assessment protocol is finalized.

QMM assessment for a site goes beyond minimum compliance (i.e., the quality system) and covers the gamut of site business processes (both GMP and non-GMP), many of which may be centralized at the corporate level across all sites. A site readiness review would, therefore, reveal the extent of effort necessary to transform the site into a more mature quality organization, which could involve updating both site-level and corporate processes and procedures. Remediation could involve updating processes and procedures, many of which could be completed relatively rapidly in the matter of months or up to a year, whereas long term, multi-year efforts may be necessary to implement more robust changes such as new technology for achieving digital maturity or manufacturing process improvements.

Corporate executives would have to pay attention to a slew of other interconnected considerations such as, but not limited to:

• Is our level of corporate centralization optimized to allow sites to focus on their core activities and still foster a proactive culture?
• Is there sufficient resiliency in our supplier ecosystem, corporate/site IT systems, and production equipment?
• Will our digital maturity strategy achieve the requisite level of cross-functional integration and maximize the use of relevant data and sources of knowledge?
• Are our site quality objectives well aligned with business objectives, and are we monitoring to ensure their realization as a measure of quality system effectiveness?
• Do our employees sufficiently understand the importance of their role in the organization and appreciate the responsibility they bear toward patients?
• Are our sites ready to promptly embrace organizational changes resulting from remediation or continuous improvement initiatives?

Pharma executives in the US and abroad should consider aligning now with the FDA QMM as part of their strategic growth plans.

The QMM initiative is directly aimed at operationalizing the vision laid out in the FDA’s report on Pharmaceutical Quality for the 21st Century: “a maximally efficient, agile, flexible manufacturing sector that reliably produced high-quality drug products without extensive regulatory oversight”⁹

Ongoing QMM efforts by FDA from 2019 to 2025 indicate that their QMM program for drug manufacturers is actively working toward full operationalization. Once finalized, the FDA QMM program is anticipated to bring wide-ranging changes in the pharma industry that could substantially disadvantage consistently low QMM-scoring pharma companies and those that don’t participate in the program. Therefore, it is imperative that manufacturers consider incorporating QMM principles into their site operations now and initiate development of an internal QMM Center of Excellence.

By proactively preparing for QMM and performing a readiness review prior to enrolling in the FDA QMM program, an organization can succeed in its efforts to achieve a more mature state of quality culture, which will make a drug manufacturer, API supplier, and CMO/CDMO attractive to both regulatory authorities and the public.

Somnath Mishra is President; William Hauck is Senior Associate; and Sarah Akers is a Consultant; all with Shabas Solutions LLC. The trio participated in a recent multi-site QMM Readiness Assessment at a global prescription drug manufacturer in Asia.

Acknowledgements: Shabas Solutions LLC sincerely acknowledges Clyde Schultz, PhD, and Zachary Royal, both members of the Shabas QMM team, which also contributed to the review of the article.

Disclosure: Shabas Solutions LLC was contracted by the FDA to plan and conduct a QMM pilot study for the foreign API manufacturers between 2020 - 2022.

Disclaimer: This article was not written by any employees of the FDA and does not reflect the views or policies of the Agency.

References

1. Mishra, S.; Hauck, W.; Royal, Z.; Michalik, R. Introduction to Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence. Pharmaceutical Technology, 2022. 46 (12). https://www.pharmtech.com/view/introduction-to-pharmaceutical-qmm-model-qmm-assessment-to-promote-pharmaceutical-operational-excellence

2. Mishra, S.; Hauck, W.; Schultz, C.; Royal, Z.; Michalik, R. QMM for Pharmaceutical Manufacturers–Implications for Drug Manufacturers, API Suppliers and Contract Manufacturers. Pharmaceutical Technology. 2023. 47 (5). https://www.pharmtech.com/view/qmm-for-pharmaceutical-manufacturers-implications-for-drug-manufacturers-api-suppliers-and-contract-manufacturers

3. Michalik, R., Hauck, W. The FDA’s Quality Management Maturity Program. Regulatory Focus. Published online July 25, 2024. https://www.raps.org/News-and-Articles/NewsArticles/2024/7/The-FDA-s-Quality-Management-Maturity-Program

4. Office of Pharmaceutical Quality (OPQ), CDER, FDA. White Paper: Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals. 2022. https://www.fda.gov/media/157432/download

5. Maguire, J.; et al. Lessons from CDER's Quality Management Maturity Pilot Programs. The AAPS Journal. 2023. 25 (1), 14. https://link.springer.com/article/10.1208/s12248-022-00777-z

6. FDA. Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities; Program Announcement. Last updated October 16, 2020. https://www.federalregister.gov/documents/2020/10/16/2020-22977/quality-management-maturity-for-active-pharmaceutical-ingredients-pilot-program-for-foreign

7. Quality Management Maturity Pilots: CDER’s Lessons Learned. May 24, 2022. https://www.fda.gov/media/166247/download?attachment

8. Maguire, J. CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development. 2023. https://www.fda.gov/media/171705/download?attachment

9. Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach Final Report. Department of Health and Human Services U.S Food and Drug Administration. FDA. 2004. https://www.fda.gov/media/77391/download