SUPPLEMENTARY INFORMATION:

I. Background

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 quality management practices that go beyond current good manufacturing practice (CGMP) requirements.^[1]

As part of the QMM program initiative, CDER is developing a QMM Assessment Tool (including both a protocol and rubric) to evaluate how effectively establishments monitor and manage quality and quality systems.^[2] In FY 2024, CDER intends to launch the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program to gain experience with use of a prototype of the assessment protocol to evaluate whether use of the protocol, as currently designed, will enable a meaningful assessment of the establishment's quality management practices and actionable feedback for the establishment. The outcomes from this prototype evaluation program will help to inform the development of the QMM Assessment Tool to be used in the eventual QMM program. This notice announces FDA's intent to launch the QMM Prototype Assessment Protocol Evaluation Program, outlines the types of establishments FDA is seeking for participation, and describes the process for submitting a request to participate in the program.

Between October 2020 and March 2022, CDER conducted under contract 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 (Ref. 1). The second pilot program evaluated the maturity of eight foreign manufacturers of active pharmaceutical ingredients (APIs) (Ref. 2). Each pilot program was conducted by a different contractor. These pilot programs provided valuable insights to CDER for developing a protocol to assess establishments' QMM, understanding assessor behaviors during interviews of establishment personnel, and gathering participant feedback on assessment questions, reports, and outcomes (Ref. 3).

Using findings from these two pilot programs, a review of the quality management maturity literature, 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 has developed a prototype assessment protocol to evaluate an establishment's QMM. The prototype assessment protocol includes a series of questions in five practice areas: leadership, 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 that may be covered under the practice areas include: management review and resource management (management commitment to quality), supply planning and demand forecasting (business continuity), corrective action and preventive action process (advanced pharmaceutical quality system), data governance and process optimization (technical excellence), and rewards and recognition (employee engagement and empowerment). CDER will use the standardized prototype assessment protocol to collect information on an establishment's executed practices, behaviors, and responses to specific questions, and will evaluate this information using an objective rubric to help identify areas of strength and potential areas with opportunities for improvement.

Prototype assessment protocols will be conducted by trained assessors who will engage directly with establishments, either onsite or in a hybrid (both virtual and onsite) environment. Assessments are anticipated to take up to five business days and are distinct from FDA's regulatory inspections.

II. Participation

A. Establishment Characteristics

CDER will consider the following establishment characteristics when identifying potential participants for this QMM Prototype Assessment Protocol Evaluation Program:

• The potential participant is an establishment as defined in21 CFR 207.1 that registers with FDA under section 510 (21 U.S.C. 360) 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 (21 U.S.C. 355) of the FD&C Act or section 351 of the Public Health Service Act (42 U.S.C. 262), 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 ^[3] in the prior 5 years.

• The current inspection classification for the establishment at the time of the request to participate is No Action Indicated or Voluntary Action Indicated.
• The establishment manufactures, prepares, propagates, compounds, or processes at least one CDER-regulated drug (API or finished drug product) that ( printed page 4952) is currently in commercial distribution in the United States.
• The establishment is willing to participate in an onsite or hybrid assessment.

B. Requests To Participate

Drug product manufacturers that are eligible and interested in participating in the voluntary QMM Prototype Assessment Protocol Evaluation Program should submit a request directly to Conchetta Newton (see FOR FURTHER INFORMATION CONTACT ). 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) FDA Establishment Identifier and Data Universal Numbering System Numbers; (4) a brief description of the business operations ( e.g., manufacturing, testing, re/packaging, re/labeling, sterilizing, storing, distributing, or salvaging) conducted at the establishment; and (5) confirmation that the establishment features the characteristics discussed in section II.A of this notice.

C. Selection Process

FDA intends to select participants that reasonably reflect the diversity of the industry. FDA intends to notify each establishment of FDA's decision on their request to participate in the voluntary QMM Prototype Assessment Protocol Evaluation Program within 90 days of receipt. FDA intends to select up to nine volunteer participants for this program.

D. FDA-Participant Interactions

FDA intends to notify selected participants of their selection and confirm participation. This notification will include more information about engagement with the Agency, including an orientation and a pre-assessment questionnaire to assist the establishment in preparing for the assessment, logistical information such as options for dates and times to schedule the assessment, and recommendations for establishment personnel that should be available during the assessment. Teams of three assessors will conduct the prototype assessment protocol over a period that is expected to be up to five business days. Each team will be composed of CDER staff, or a combination of CDER staff and contractors. Following completion of the assessment, each participating establishment will receive a report summarizing areas of strength and growth opportunities. In addition, approximately 6 months after the assessment, FDA will followup with a virtual meeting to get feedback on the prototype assessment protocol, the report, and any limitations encountered. This will help the Agency evaluate use of the protocol, including whether it enables meaningful assessment of the establishment's quality management practices and if feedback for the establishment is actionable.

III. References

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.

* 1. Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement,” 85 FR 65824, October 16, 2020, https://www.federalregister.gov/​d/​2020-22976.

* 2. “Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities; Program Announcement,” 85 FR 65828, October 16, 2020, https://www.federalregister.gov/​d/​2020-22977.

3. J. Maguire, A. Fisher, D. Harouaka, N. Rakala, et al., 2023, “Lessons from CDER's Quality Management Maturity Pilot Programs,” AAPS Journal, 25(14), January 10, 2023, https://doi.org/​10.1208/​s12248-022-00777-z.