Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2023-N-5706]</DEPDOC> <SUBJECT>Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the second year of the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). The Center of Drug Evaluation and Research (CDER) implemented this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with, and further refine as necessary, the prototype assessment protocol and process, to help enable consistent and meaningful assessment of participating establishments' quality management practices, and to provide useful feedback to participants. This notice announces CDER's intent to continue the voluntary QMM Prototype Assessment Protocol Evaluation Program, outlines the types of establishments CDER is seeking for participation, and describes the process for submitting a request to participate in the program. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> CDER intends to accept requests to participate in the voluntary QMM Prototype Assessment Protocol Evaluation Program through June 9, 2025. See the “Participation” section of this document for instructions on submitting a request to participate and the selection process. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> For questions about the voluntary QMM Prototype Assessment Protocol Evaluation Program: Djamila Harouaka, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4160, Silver Spring, MD 20993-0002, 240-402-0224, <E T="03">CDER-QMM@fda.hhs.gov.</E> To submit a request to participate in the program: Conchetta Newton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4144, 240-402-6551, <E T="03">CDER-QMM@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> QMM refers to the extent to which drug manufacturing establishments implement quality management practices that prioritize patients, drive continual improvement, and enhance supply chain reliability through the strategic integration of business decisions and manufacturing operations with quality practices and technological advancements. CDER is in the process of developing a voluntary program to promote QMM at drug manufacturing establishments, which would encourage drug manufacturers to implement or improve their quality management practices. <SU>1</SU> <FTREF/> <FTNT> <SU>1</SU>  In 2023, CDER solicited comments to inform the development of a future QMM program. Then, in 2024, CDER initiated a voluntary QMM Prototype Assessment Protocol Evaluation Program. See 88 FR 63587, September 15, 2023, and 89 FR 4950, January 25, 2024, respectively. </FTNT> Between October 2020 and March 2022, CDER conducted two pilot programs to assess the QMM of drug manufacturing establishments. The first pilot program evaluated the maturity of seven domestic manufacturers of finished dosage forms for the U.S. market. <SU>2</SU> <FTREF/> The second pilot program evaluated the maturity of eight foreign manufacturers of active pharmaceutical ingredients (APIs). <SU>3</SU> <FTREF/> Each pilot program was conducted by a different contractor. These pilot programs provided valuable insights for CDER to develop a protocol to assess establishments' QMM, understand assessor behaviors during interviews of establishment personnel, and gather participant feedback on assessment questions, reports, and outcomes. <SU>4</SU> <FTREF/> <FTNT> <SU>2</SU>  Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement, 85 FR 65824, October 16, 2020, <E T="03">https://www.federalregister.gov/d/2020-22976.</E> </FTNT> <FTNT> <SU>3</SU>  Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities; Program Announcement, 85 FR 65828, October 16, 2020, <E T="03">https://www.federalregister.gov/d/2020-22977.</E> </FTNT> <FTNT> <SU>4</SU>  Maguire, J., A. Fisher, D. Harouaka, et al., “Lessons from CDER's Quality Management Maturity Pilot Programs,” AAPS J, 25(14), January 10, 2023, <E T="03">https://doi.org/10.1208/s12248-022-00777-z.</E> </FTNT> Using the findings from these two pilot programs, a review of the literature on quality management, evaluations of existing external programs assessing elements of quality culture or pharmaceutical quality, surveys of external stakeholders, and feedback from partner offices and centers within FDA, CDER developed a prototype assessment protocol to evaluate an establishment's QMM. <SU>5</SU> <FTREF/> This prototype assessment protocol included a series of questions in five practice areas: management commitment to quality, <SU>6</SU> <FTREF/> business continuity, technical excellence, advanced pharmaceutical quality system, and employee empowerment and engagement. Within each practice area, the prototype assessment protocol explores key elements of the establishment's QMM. Examples of some topics covered under the practice areas include management review and resource management (management commitment to quality), supply planning and demand forecasting (business continuity), continual improvement  <SU>7</SU> <FTREF/> (advanced pharmaceutical quality system), data governance and process optimization (technical excellence), and rewards and recognition (employee engagement and empowerment). <FTNT> <SU>5</SU>  For additional information, see CDER's “Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development” (2023), available at <E T="03">https://www.fda.gov/media/171705/download.</E> </FTNT> <FTNT> <SU>6</SU>  Note that this practice area was previously referred to as `leadership' (89 FR 4950 at 4951). We have since modified this to “management commitment to quality” to align with what the practice area was titled at the time that specific prototype was developed and as discussed in our 2023 QMM white paper: CDER's Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development (see <E T="03">https://www.fda.gov/media/171705/download</E> ). “Management Commitment to Quality” more accurately reflects the topic areas covered in this practice area. </FTNT> <FTNT> <SU>7</SU>  Note that the example in the previous <E T="04">Federal Register</E> Notice (89 FR 4950 at 4951) was “corrective action and preventive action process” (89 FR 4950 at 4951). That has since been replaced with “Continual improvement” as an example to align with modifications that were made to the prototype assessment protocol. </FTNT> In 2024, CDER evaluated nine establishments in the voluntary QMM Prototype Assessment Protocol Evaluation Program. <SU>8</SU> <FTREF/> CDER used the prototype assessment protocol to collect information on each establishment's practices, behaviors, and responses to specific questions in five practice areas. The information collected was evaluated using an objective rubric. Trained assessors conducted 5-day assessments and provided establishments with a QMM report following the assessment. Each QMM report highlighted the establishment's strengths and opportunities for improvement. Feedback from voluntary participants indicated that engagement with the QMM assessment team and the QMM reports were favorably received and provided value to the establishments. However, participants also indicated that certain aspects of the prototype assessment protocol were repetitive and suggested that the protocol should be streamlined. <FTNT> <SU>8</SU>  See 89 FR 4950, January 25, 2024. </FTNT> The 2024 QMM Prototype Assessment Protocol Evaluation Program provided CDER with experience in the successful application of the prototype assessment tool across a group of volunteer establishments that reasonably reflected the diversity of the industry. The rubric effectively differentiated the maturity of quality management practices across the nine establishments assessed in 2024. Using the feedback received and insights gained from 2024, CDER modified its prototype QMM assessment tool to be clearer and more concise and updated the rubric. We also modified how some of the questions are framed for greater clarity. CDER intends to evaluate these improvements and further refine the prototype protocol as necessary by continuing the voluntary program and offering the opportunity to establishments that wish to volunteer to participate in 2025. This notice announces CDER's intent to continue the voluntary QMM Prototype Assessment Protocol Evaluation Program, outlines the types of establishments CDER is seeking for participation, and describes the process for submitting a request to participate in the program. <HD SOURCE="HD1">II. Participation</HD> <HD SOURCE="HD2">A. Establishment Characteristics</HD> CDER will consider the following establishment characteristics when identifying potential participants for this voluntary QMM Prototype Assessment Protocol Evaluation Program: • The potential participant is an establishment as defined in 21 CFR 207.1 that registers with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 16k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━