Notice2024-01423
Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
Primary source
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Published
January 25, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 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.
Full Text
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<title>Federal Register, Volume 89 Issue 17 (Thursday, January 25, 2024)</title>
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[Federal Register Volume 89, Number 17 (Thursday, January 25, 2024)]
[Notices]
[Pages 4950-4952]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#db989f9e89f68a96969bbdbfbaf5b3b3a8f5bcb4ad"><span class="__cf_email__" data-cfemail="76353233245b273b3b36101217581e1e0558111900">[email protected]</span></a>.
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, <a href="/cdn-cgi/l/email-protection#c083848592ed918d8d80a6a4a1eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="62212627304f332f2f220406034c0a0a114c050d14">[email protected]</span></a>.
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 <a href="https://www.fda.gov/media/171705/download?attachment">https://www.fda.gov/media/171705/download?attachment</a>.
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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:
<bullet> 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).
<bullet> 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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<bullet> The current inspection classification for the
establishment at the time of the request to participate is No Action
Indicated or Voluntary Action Indicated.
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="https://www.federalregister.gov/d/2020-22976">https://www.federalregister.gov/d/2020-22976</a>.
* 2. ``Quality Management Maturity for Active Pharmaceutical
Ingredients Pilot Program for Foreign Facilities; Program
Announcement,'' 85 FR 65828, October 16, 2020, <a href="https://www.federalregister.gov/d/2020-22977">https://www.federalregister.gov/d/2020-22977</a>.
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, <a href="https://doi.org/10.1208/s12248-022-00777-z">https://doi.org/10.1208/s12248-022-00777-z</a>.
Dated: January 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01423 Filed 1-24-24; 8:45 am]
BILLING CODE 4164-01-P
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