[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65828-65830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22977]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2018]


Quality Management Maturity for Active Pharmaceutical Ingredients 
Pilot Program for Foreign Facilities; Program Announcement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency), Center for 
Drug Evaluation and Research (CDER) is announcing its Quality 
Management Maturity for Active Pharmaceutical Ingredients Pilot Program 
(QMM API Pilot Program) for foreign facilities manufacturing active 
pharmaceutical ingredients (APIs), including facilities manufacturing 
drug substance intermediates used to produce APIs, that are used in 
FDA-regulated prescription and over-the-counter (OTC) drug products. 
The purpose of the QMM API Pilot Program is to gain insight from third-
party assessments of a facility's quality management system to inform 
future development of an FDA rating system to characterize quality 
management maturity (QMM). Such a rating system would allow a cross-
sectional comparison of facilities. Facilities that choose to disclose 
their facility ratings to drug product manufacturers could benefit from 
a competitive advantage, as knowledge of QMM ratings would enable drug 
product manufacturers to differentiate among facilities when purchasing 
APIs. This notice invites foreign facilities that are interested in 
participating in the QMM API Pilot Program to submit a request to 
participate.

DATES: FDA will accept requests to participate in the QMM API Pilot 
Program through November 30, 2020, and the QMM API Pilot Program will 
run through December 31, 2021. See the ``Participation'' section for 
selection criteria and instructions on how to submit a request to 
participate.

FOR FURTHER INFORMATION CONTACT: For general questions about the QMM 
API Pilot Program: Jennifer Maguire, Center for Drug Evaluation and 
Research (CDER), 10903 New Hampshire Ave., Bldg. 51, Rm. 4134, Silver 
Spring, MD 20993, 240-402-4817, [email protected].
    To submit a request to participate in the QMM API Pilot Program: 
Seongjin (Cindy) Pak, CDER, 10903 New Hampshire Ave., Bldg. 51, Rm. 
4220, 301-796-1673, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In 2002, FDA launched an initiative ``Pharmaceutical CGMPs for the 
21st Century--A Risk-Based Approach,'' to enhance and modernize the 
regulation of pharmaceutical manufacturing and product quality.\1\ One 
objective, among others, was to facilitate the implementation of a 
modern, risk-based

[[Page 65829]]

pharmaceutical quality assessment system. The desired goal has been 
described as a maximally efficient, agile, flexible pharmaceutical 
manufacturing sector that reliably produces high-quality drug products 
without extensive regulatory oversight.
---------------------------------------------------------------------------

    \1\ See FDA's final report: ``Pharmaceuticals CGMPs for the 21st 
Century--A Risk-Based Approach'' (September 2004) at https://www.fda.gov/media/77391/download.
---------------------------------------------------------------------------

    There has been significant progress toward this vision as evidenced 
by FDA programs and initiatives in such areas as pharmaceutical 
development and quality by design, quality risk management and 
pharmaceutical quality systems, process validation, and emerging 
technologies. These programs and initiatives promote use of the best 
pharmaceutical science and engineering principles throughout the 
product life cycle.
    Another example is the FDA Quality Metrics Program, described in 
the November 2016 revised draft guidance for industry, ``Submission of 
Quality Metrics Data'' (81 FR 85226). When final, this guidance will 
represent FDA's current thinking on this issue. In June 2018, FDA 
initiated two voluntary programs that sought additional industry input 
on quality metrics. FDA solicited industry participation for a Site 
Visit Program (83 FR 30751) for manufacturing establishments to present 
the advantages and challenges associated with implementing and managing 
a quality metrics program and for a Quality Metrics Feedback Program 
(83 FR 30748) to engage stakeholders in identifying mutually useful and 
objective quality metrics.
    The Agency continues to develop the FDA Quality Metrics Program but 
recognizes that quality metrics are only one element within a 
manufacturer's larger effort to increase the maturity of their quality 
management system. Manufacturers that demonstrate QMM \2\ operate under 
an enhanced quality management system that exceeds the minimum 
standards specified in current good manufacturing practice regulations 
and focuses on continual improvement. Characteristics of a mature 
quality management system include, for example, the ability to 
consistently and reliably deliver quality product over time, 
operational stability, and a strong quality culture. Additionally, for 
manufacturers with a mature quality management system, FDA can exercise 
a more flexible regulatory approach, leading toward the goal of 
producing high-quality drug products without extensive regulatory 
oversight.
---------------------------------------------------------------------------

    \2\ For additional information on quality management maturity, 
see FDA's Report: ``Drug Shortages: Root Causes and Potential 
Solutions'' (October 2019) at https://www.fda.gov/media/131130/download.
---------------------------------------------------------------------------

    A transparent method of evaluating and communicating QMM is needed 
to fully realize the 21st century pharmaceutical quality vision. Toward 
that end, FDA is announcing the start of the QMM API Pilot Program. 
Through this pilot program, a third-party contractor identified by the 
FDA will conduct an assessment of a facility's quality management 
system, accompanied by FDA staff. The Agency will gain insight from the 
results of the QMM assessments to inform the development of a rating 
system to measure and rate QMM. Assessments under the QMM API Pilot 
Program will cover multiple topics. Examples include but are not 
limited to:
    1. Supply chain management;
    2. manufacturing strategy and operations;
    3. safety, environmental, and regulatory compliance;
    4. inventory management;
    5. performance management and continual improvement;
    6. risk management;
    7. management review and responsibility;
    8. planning;
    9. workforce management;
    10. quality culture; and
    11. customer experience.
    In the same timeframe as the QMM API Pilot Program, FDA will 
conduct a QMM pilot program for domestic manufacturers of finished 
dosage forms (FDF). These pilot programs are funded separately and are 
intended to provide FDA with representative information about QMM from 
different types of drug manufacturers (API and FDF). Elsewhere in this 
issue of the Federal Register, FDA is publishing ``Quality Management 
Maturity for Finished Dosage Forms Pilot Program for Domestic Drug 
Product Manufacturers; Program Announcement.''

II. Participation

    Facilities located outside the United States that manufacture APIs 
or drug substance intermediates used to produce APIs and are interested 
in participating in the QMM API Pilot Program should submit a written 
request directly to Seongjin (Cindy) Pak (see FOR FURTHER INFORMATION 
CONTACT). Participation is voluntary. Participants in the Quality 
Metrics Feedback Program are encouraged to participate in the QMM API 
Pilot Program. FDA will select up to nine participants for the QMM API 
Pilot Program. Participation in the QMM API Pilot Program is limited to 
foreign manufacturing facilities since FDA's funding source for this 
program is specific to activities related to the surveillance of 
foreign sites.

A. Selection Criteria

    To be considered for the QMM API Pilot Program, participants must 
meet the following selection criteria:
    1. Participant is a facility located outside the United States that 
manufactures APIs or drug substance intermediates used to produce APIs 
for FDA-regulated prescription and OTC drug products. Facilities 
located in Puerto Rico or other U.S. territories are not considered to 
be foreign facilities and thus are not eligible to participate in the 
QMM API Pilot Program.
    2. All FDA inspection(s) of the manufacturing facility conducted 
within the 5 years prior to September 15, 2020, received a final 
classification of ``No Action Indicated'' or ``Voluntary Action 
Indicated.''
    3. Participant agrees to:
    a. Permit a third-party contractor to conduct a QMM assessment, 
whether the assessment is conducted on-site or remotely. FDA will 
identify an external contractor having the expertise to assess QMM, and 
FDA staff will join the contractor for the assessment.
    b. Collect and submit metric data to FDA and the contractor by an 
agreed upon date, prior to the assessment. As part of the scoping 
discussions for the assessment, FDA will provide the facility with 
templates and additional details about the data collection.
    c. Be available for consultations with the contractor and FDA prior 
to and after the assessment, including discussions regarding the 
participant's established QMM-related activities and the contractor's 
post-assessment recommendations regarding these activities.
    During this QMM API Pilot Program, the contractor and FDA staff 
will be available to answer questions and address concerns that arise.

B. Information To Include in the Request

    When submitting a request to participate in the QMM API Pilot 
Program, include the information below to aid in FDA's selection and 
planning. FDA will not consider requests submitted without the 
following minimal information:
    1. A contact person (name and email);
    2 facility location;
    3. facility FDA Establishment Identifier and Data Universal 
Numbering System numbers;
    4. a brief description of the manufacturing operations conducted at 
the facility;
    5. preferred dates for the assessment;

[[Page 65830]]

    6. written confirmation that the facility meets the selection 
criteria in section II.A, including agreement to items 3a-c;
    7. written confirmation that the facility can handle a visit of up 
to 10 FDA staff and contractors; and
    8. a brief description of prior experiences undergoing an 
assessment related to the maturity of the facility's quality culture, 
including the name of the organization that conducted the assessment 
and date of the assessment.

    Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22977 Filed 10-15-20; 8:45 am]
BILLING CODE 4164-01-P