[Federal Register Volume 89, Number 17 (Thursday, January 25, 2024)]
[Notices]
[Pages 4950-4952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01423]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-5706]


Voluntary Quality Management Maturity Prototype Assessment 
Protocol Evaluation Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for a limited number of establishments to participate in 
a voluntary Quality Management Maturity Prototype Assessment Protocol 
Evaluation Program involving the use of a prototype assessment protocol 
to evaluate quality management maturity (QMM). The Center for Drug 
Evaluation and Research (CDER) is implementing this voluntary program 
for manufacturers of CDER-regulated drug products to gain experience 
with the prototype assessment protocol and to evaluate whether use of 
the protocol, as designed, will enable a meaningful assessment of the 
establishment's

[[Page 4951]]

quality management practices while providing useful feedback for the 
establishment. This notice outlines the types of establishments FDA is 
seeking for participation and the process for submitting a request to 
participate in the program.

DATES: FDA intends to accept requests to participate in the voluntary 
QMM Prototype Assessment Protocol Evaluation Program through March 25, 
2024. See the ``Participation'' section of this document for 
instructions on submitting a request to participate and the selection 
process.

FOR FURTHER INFORMATION CONTACT: 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, [email protected].
    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, [email protected].

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\
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    \1\ FDA has solicited comments to inform the development of this 
program. See 88 FR 63587, September 15, 2023.
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    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.
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    \2\ For additional information, see CDER's Quality Management 
Maturity (QMM) Program: Practice Areas and Prototype Assessment 
Protocol Development (2023), available at https://www.fda.gov/media/171705/download?attachment.
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    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 
in 21 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.
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    \3\ Inspections conducted by FDA or by Mutual Recognition 
Agreement (MRA) partners and classified by FDA would fulfill this 
criterion. See Mutual Recognition Agreements (MRA) for more 
information.
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     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

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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.

    Dated: January 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01423 Filed 1-24-24; 8:45 am]
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