Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability, 563-565 [2024-31356]

Download as PDF 563 Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Rules and Regulations Country License requirement Entity Room 2005, Building 6, No. 77 Heshun Road, Suzhou Industrial Park, Suzhou, Jiangsu, 215000, China; and Room 301 Building 3, No. 99 Jinyahu Avenue, Suzhou Industrial Park, Jiangsu Pilot Free Trade Zone, China. * * Wuhu Kewei Zhaofu Electronics Co., Ltd., West side of North Jiuhua Road, Economic and Technological Development Zone, Wuhu, Anhui, China; and No.10 Ruifu Road, Longshan Avenue, Wuhu Economic and Technological Development Zone, Wuhu, Anhui, 241000, China. * * Yaguang Technology Group Co., Ltd., a.k.a., the following one alias: —Sunbird Yachting Co., Ltd. Yacht Industrial Park, Yuanjiang, China; and No. 18, Shijihu Road, Yuanjiang City, Yiyang City, China; and Yaguang Science and Technology Park, No. 1820 Yuelu West Avenue, Changsha, China. * * * PAKISTAN ............ * * * * * * * Matthew S. Borman, Principal Deputy Assistant Secretary for Strategic Trade and Technology Security. [FR Doc. 2024–31468 Filed 1–3–25; 8:45 am] BILLING CODE 3510–33–P 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and Drug Administration 21 CFR Part 211 [Docket No. FDA–2024–D–5374] Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. khammond on DSK9W7S144PROD with RULES ACTION: Availability of draft guidance. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Considerations for Complying With 21 CFR 211.110.’’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 SUMMARY: VerDate Sep<11>2014 16:06 Jan 03, 2025 Jkt 265001 * Presumption of denial. * 90 FR [INSERT FR PAGE NUMBER AND 1/6/25. * * For all items subject to the EAR. (See § 744.11 of the EAR). * Presumption of denial. * 90 FR [INSERT FR PAGE NUMBER AND 1/6/25. * * * * * * * * For all items subject to the EAR. (See § 744.11 of the EAR). * * * * * 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 Frm 00033 Fmt 4700 Sfmt 4700 * 90 FR [INSERT FR PAGE NUMBER AND 1/6/25. * * Electronic Submissions * * * Presumption of denial. 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: PO 00000 Federal Register citation * * For all items subject to the EAR. (See § 744.11 of the EAR). * * * Emerging Future Solutions Private Limited, a.k.a., the following four aliases: —Emerging Future Solutions; —Emerging Future Solutions (Pvt) Ltd Pakistan; —Emerging Future Solutions Pvt Ltd.; and —Emerging Future Solutions Limited. Office No. 46–A, Street No. 5, Chaklala SchemeIII, Rawalpindi, 46000, Pakistan. * * License review policy * * * 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 E:\FR\FM\06JAR1.SGM 06JAR1 khammond on DSK9W7S144PROD with RULES 564 Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Rules and Regulations 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-201509-18/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 VerDate Sep<11>2014 16:06 Jan 03, 2025 Jkt 265001 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 § 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 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. PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 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 § 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. 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 § 211.110. However, control strategies that rely solely on current process models would be insufficient to satisfy the requirements of § 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 inprocess 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 2 See E:\FR\FM\06JAR1.SGM § 211.110. 06JAR1 Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Rules and Regulations 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 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-regulatoryinformation/guidances-drugs, https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics, https:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, 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] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG–2024–1099] Security Zone; Potomac River and Anacostia River, and Adjacent Waters, Washington, DC Coast Guard, Department of Homeland Security (DHS). ACTION: Notification of enforcement of regulation. khammond on DSK9W7S144PROD with RULES AGENCY: 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). VerDate Sep<11>2014 16:06 Jan 03, 2025 Jkt 265001 The Coast Guard will enforce a security zone along the Potomac River, Anacostia River, and adjacent waters at Washington, DC, for the State Funeral for former President James Carter. This action is necessary to protect government officials, mitigate potential terrorist acts and incidents, and enhance public and maritime safety and security immediately before, during, and after this activity. During the enforcement period, entry into or remaining within the zone is prohibited unless authorized by the Captain of the Port or their designated representative. DATES: The regulations in 33 CFR 165.508 will be enforced from 8 a.m., January 7, 2025, through 4 p.m., January 9, 2025, for the security zone location identified in 33 CFR 16.508(a)(6). FOR FURTHER INFORMATION CONTACT: If you have questions about this notification of enforcement, call or email LCDR Kate Newkirk, U.S. Coast Guard Sector Maryland-National Capital Region, Waterways Management Division; telephone 410–576–2596, email Kate.M.Newkirk@uscg.mil. SUPPLEMENTARY INFORMATION: The Coast Guard will enforce regulations in 33 CFR 165.508 for the locations identified in paragraph (a)(6) from 8 a.m., January 7, 2025, through 4 p.m., January 9, 2025. This action is being taken to protect government officials, mitigate potential terrorist acts and incidents, and enhance public and maritime safety and security immediately before, during, and after this event. Our regulations for the Security Zone; Potomac River and Anacostia River, and adjacent waters at Washington, DC. The regulation at 33 CFR 165.508(a)(6) specifies the location for this security zone as an area that includes all navigable waters described in paragraphs (a)(1) through (3), which includes Zones 1, 2, and 3. • Security Zone 1, paragraph (a)(1); all navigable waters of the Potomac River, from shoreline to shoreline, bounded to the north by the Francis Scott Key (US–29) Bridge, at mile 113, and bounded to the south by a line drawn from the Virginia shoreline at Ronald Reagan Washington National Airport at 38°51′21.3″ N, 077°02′00.0″ W, eastward across the Potomac River to the District of Columbia shoreline at Hains Point at position 38°51′24.3″ N, 077°01′19.8″ W, including the waters of the Boundary Channel, Pentagon Lagoon, Georgetown Channel Tidal Basin, and Roaches Run. • Security Zone 2, paragraph (a)(2); all navigable waters of the Anacostia River, from shoreline to shoreline, bounded to the north by the John Philip Sousa (Pennsylvania Avenue) Bridge, at SUMMARY: PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 565 mile 2.9, and bounded to the south by a line drawn from the District of Columbia shoreline at Hains Point at position 38°51′24.3″ N, 077°01′19.8″ W, southward across the Anacostia River to the District of Columbia shoreline at Giesboro Point at position 38°50′52.4″ N, 077°01′10.9″ W, including the waters of the Washington Channel. • Security Zone 3 paragraph (a)(3); all navigable waters of the Potomac River, from shoreline to shoreline, bounded to the north by a line drawn from the Virginia shoreline at Ronald Reagan Washington National Airport, at 38°51′21.3″ N, 077°02′00.0″ W, eastward across the Potomac River to the District of Columbia shoreline at Hains Point at position 38°51′24.3″ N, 077°01′19.8″ W, thence southward across the Anacostia River to the District of Columbia shoreline at Giesboro Point at position 38°50′52.4″ N, 077°01′10.9″ W, and bounded to the south by the Woodrow Wilson Memorial (I–95/I–495) Bridge, at mile 103.8. During the enforcement period, as specified in § 165.508(b), entry into or remaining in these zones is prohibited unless authorized by the Coast Guard Captain of the Port Maryland-National Capital Region. Public vessels and vessels already at berth at the time of the security zone is implemented do not have to depart the security zone. All vessels underway within the security zone at the time the security zone is implemented are to depart the zone. To seek permission to transit the zone, the Captain of the Port Maryland-National Capital Region can be contacted at telephone number (410) 576–2525 or on Marine Band Radio, VHF–FM channel 16 (156.8 MHz). Coast Guard vessels enforcing this zone can be contacted on Marine Band Radio, VHF–FM channel 16 (156.8 MHz). The Coast Guard may be assisted by other Federal, state, or local law enforcement agencies in enforcing this regulation. If the Captain of the Port or his designated on-scene patrol personnel determines the security zone need not be enforced for the full duration stated in this notification, a Broadcast Notice to Mariners may be used to suspend enforcement and grant general permission to enter the security zone. In addition to this notification of enforcement in the Federal Register, the Coast Guard plans to provide notification to this enforcement period via the Local Notice to Mariners, and marine information broadcasts. E:\FR\FM\06JAR1.SGM 06JAR1

Agencies

[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]


=======================================================================
-----------------------------------------------------------------------

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.

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

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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]
BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.