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) is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the third year of the voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program. The Center for Drug Evaluation and Research (CDER) is implementing this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with the assessment tool and process. The continuation of this voluntary program is needed to assure that these assessments enable consistent and meaningful evaluations of establishments' quality management practices and provide useful feedback for the establishments. This notice outlines the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> FDA intends to accept requests to participate in the voluntary QMM Prototype Assessment Protocol Evaluation Program through April 13, 2026. See the “Participation” section of this document for instructions on submitting a request to participate and for information about the selection process. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> For questions about the voluntary QMM Prototype Assessment Protocol Evaluation Program, contact 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, contact Conchetta Newton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Building 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 has developed a voluntary QMM program to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements. <SU>1</SU> <FTREF/> <FTNT> <SU>1</SU>  FDA has solicited comments to inform the development of this program. See 88 FR 63587, September 15, 2023. </FTNT> Following completion of the first year of the program, CDER refined the prototype QMM assessment tool (including both a protocol and rubric), which is used to evaluate how effectively establishments monitor and manage quality and quality systems. <SU>2</SU> <FTREF/> In CY 2026, CDER intends to continue the voluntary QMM Prototype Assessment Protocol Evaluation Program to evaluate a drug manufacturing establishment's quality management practices and provide actionable feedback for the establishment. This notice announces CDER's intent to continue the 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. <FTNT> <SU>2</SU>  For additional information, see <E T="03">CDER's Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development</E> (2023), available at <E T="03">https://www.fda.gov/media/171705/download?attachment.</E> </FTNT> In 2024, CDER evaluated nine establishments during the initial year of the voluntary QMM Prototype Assessment Protocol Evaluation Program. <SU>3</SU> <FTREF/> CDER used a standardized prototype assessment protocol and rubric to evaluate each establishment's practices, behaviors, and responses to specific questions. Feedback from participants in the first year of the program indicated that the QMM report, engagement with the assessment team, and the ability to have open discussions provided value to establishments and highlighted strengths and opportunities for improvement. In addition, participating establishments were able to share challenges and successes related to their manufacturing sectors. <FTNT> <SU>3</SU>  See 89 FR 4950, January 25, 2024. </FTNT> The 2024 QMM program provided CDER with experience in the successful application of the standardized prototype assessment protocol and rubric at nine drug manufacturing establishments. The nine establishments represented a range of manufacturing sectors ( <E T="03">e.g.,</E> generic drug manufacturers, contract testing laboratory, brand drug manufacturers) in the pharmaceutical industry. The prototype assessment protocol and rubric distinguished differences in maturity levels between practice areas at a single establishment. Differences in maturity levels were also clearly discerned between establishments. Using the insights gained from these experiences, CDER streamlined the QMM assessment tool to make the prototype protocol and rubric clearer and more concise. CDER is now evaluating the refined assessment tool at more establishments in the second year of the QMM Prototype Assessment Protocol Evaluation Program, which is ongoing. Through this announcement, CDER is offering an opportunity for additional establishments to volunteer to participate. This will allow CDER to gain further experience with the assessment tool, expand our knowledge of quality management practices in the industry, and provide additional drug manufacturing establishments with actionable feedback. <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 the third year of the 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 manufactures, prepares, propagates, compounds, or processes drugs, or APIs used in such drugs, subject to approval or licensure under section 505 of the FD&C Act or section 351 of the Public Health Service Act, or that are marketed pursuant to section 505G of the FD&C Act without an approved application under section 505 of the FD&C Act (often referred to as over-the-counter (OTC) monograph drug products). • The establishment received at least one human drug surveillance inspection. <SU>4</SU> <FTREF/> <FTNT> <SU>4</SU>  Inspections conducted by FDA or by Mutual Recognition Agreement (MRA) partners and classified by FDA would fulfill this criterion. </FTNT> • The current inspection classification for the establishment at the time of the request to participate is No Action Indicated (NAI) or Voluntary Action Indicated (VAI). • The establishment manufactures, prepares, propagates, compounds, or processes at least one CDER-regulated drug (API or finished drug product) that is currently in commercial distribution in the U.S. • The establishment is willing to participate in an onsite or hybrid assessment. <HD SOURCE="HD2">B. Requests To Participate</HD> Drug product manufacturers that meet the establishment characteristics described in section II.A and are interested in participating in the voluntary QMM Prototype Assessment Protocol Evaluation Program should submit a request directly to Conchetta Newton (see <E T="02">FOR FURTHER INFORMATION CONTACT</E> ). To be considered for this program, a request should include all the following information: (1) A contact person (name and email). (2) Manufacturing establishment address. (3) Establishment FDA Establishment Identifier (FEI) and Data Universal Numbering System Numbers (DUNS). (4) A brief description of the business operations ( <E T="03">e.g.,</E> manufacturing, testing, re/packaging, re/labeling, sterilizing, storing, distributing, or salvaging) conducted at the establishment. Please indicate whether the establishment produces active pharmaceutical ingredients (APIs), generic drugs, innovator drugs, over-the-counter (OTC) drugs, biological drug products, and if the establishment is a contract manufacturing or contract testing organization. (5) Confirmation that the establishment features the characteristics discussed in section II.A of this notice. <HD SOURCE="HD2">C. Selection Process</HD> CDER intends to select participants that reasonably reflect the diversity of the industry. CDER intends to notify each establishment of a decision on their request to participate within 60 days of receipt. CDER intends to select up to nine volunteer participants for this program. <HD SOURCE="HD2">D. FDA-Participant Interactions</HD> CDER intends to notify participants of their selection and confirm their willingness to participate. Selected participants will receive orientation materials which will contain additional information about program timelines, milestones, and expectations. Participating establishments will also receive a pre-assessment questionnaire, which will provide them with specific topic areas that will be covered during the assessment. The pre-assessment questionnaire is intended to help establishments prepare for the assessment and identify the relevant subject matter exp ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 12k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━