[Federal Register Volume 90, Number 3 (Monday, January 6, 2025)]
[Rules and Regulations]
[Pages 563-565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31356]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 211
[Docket No. FDA-2024-D-5374]
Considerations for Complying With 21 CFR 211.110; Draft Guidance
for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Availability of draft guidance.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Considerations for Complying With 21 CFR 211.110.'' This guidance,
when finalized, will describe considerations for complying with the
requirements for ensuring batch uniformity and drug product integrity.
In addition, this guidance discusses related quality considerations for
drug products that are manufactured using advanced manufacturing. FDA
is committed to supporting and enabling pharmaceutical innovation and
modernization as part of the Agency's mission to protect and promote
the public health. FDA encourages industry representatives and
manufactures who are interested in using innovative control strategies
to contact the Agency.
DATES: Submit either electronic or written comments on the draft
guidance by April 7, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management
[[Page 564]]
Staff, FDA will post your comment, as well as any attachments, except
for information submitted, marked and identified, as confidential, if
submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-D-5374 for ``Considerations for Complying With 21 CFR
211.110.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
Policy and Regulations Staff, HFV-6, Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Brittany Avaritt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6649, Silver Spring, MD 20993-0002, 240-
402-5982; James Myers, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bld. 71, Rm.
7301, Silver Spring, MD 20993-002, 240-402-7911; or Kevin Rice, Center
for Veterinary Medicine, Food and Drug Administration, 7500 Standish
Place, Rockville, MD 20855, 240-402-0680.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Considerations for Complying with 21 CFR 211.110.'' This
guidance, when finalized, will describe considerations for complying
with the requirements in Sec. 211.110 (21 CFR 211.110) to ensure batch
uniformity and drug product integrity. In addition, this guidance
discusses related quality considerations for drug products that are
manufactured using advanced manufacturing. It also discusses how
manufacturers can incorporate process models into commercial
manufacturing control strategies. This guidance applies to the
manufacture of human drug products, including biological products, and
animal drug products. This guidance does not apply to the manufacture
of active ingredients.
To ensure batch uniformity and drug product integrity, the current
good manufacturing practice (CGMP) regulations \1\ require, among other
things, that manufacturing processes are designed and controlled to
ensure that in-process materials consistently and reliably meet
predetermined quality requirements.\2\ This guidance explains the
requirements for drug product manufacturing in Sec. 211.110. This
guidance also describes considerations for the use of advanced
manufacturing (e.g., 3D printing, continuous manufacturing) and the use
of process models as a part of commercial manufacturing control
strategies. FDA supports the adoption of advanced manufacturing as a
foundation for improving the overall quality and availability of drug
products for patients.
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\1\ See 21 CFR parts 210 and 211. Positron emission tomography
drug products are subject to CGMP regulations at 21 CFR part 212 and
are not covered by this guidance.
\2\ See Sec. 211.110.
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All manufacturers, regardless of whether they are using advanced
manufacturing, should apply a scientific- and risk-based approach to
controlling processes and ensuring drug product quality. This approach
should be based on robust product and process understanding. Advanced
manufacturing (such as continuous manufacturing) generally lends itself
to more extensive understanding and control of the manufacturing
process; thus, it is generally suitable for implementing process models
as part of the control strategy. FDA is aware of industry's interest in
using in-process control strategies that rely solely on process models
to satisfy the requirements of Sec. 211.110. However, control
strategies that rely solely on current process models would be
insufficient to satisfy the requirements of Sec. 211.110.
FDA is committed to supporting and enabling pharmaceutical
innovation and modernization as part of the Agency's mission to protect
and promote the public health. This guidance provides information on
how process models can be paired with in-process material testing or
process monitoring to meet current regulatory requirements. As the
science supporting innovative in-process control tools and methods
continues to develop, FDA anticipates that these scientific
advancements can be leveraged to pursue in-process control strategies
that increasingly rely on process models. FDA encourages industry
representatives and manufacturers to discuss their proposed innovative
control strategies with the Agency to help inform future policy
development.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Considerations for Complying With
[[Page 565]]
21 CFR 211.110.'' It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.\3\
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\3\ The Office of the Federal Register has published this
document under the category ``Rules and Regulations'' pursuant to
its interpretation of 1 CFR 5.9(b). We note that the categorization
as such for purposes of publication in the Federal Register does not
affect the content or intent of the document. See 1 CFR 5.1(c).
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II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
parts 210 and 211 relating to CGMP have been approved under OMB control
number 0910-0139.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: December 23, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31356 Filed 1-3-25; 8:45 am]
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