Notice2021-27351
Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry; Availability
Primary source
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Published
December 17, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Inspection of Injectable Products for Visible Particulates." Visible particulates in injectable products can jeopardize patient safety. This draft guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination. The draft guidance also clarifies that meeting an applicable U.S. Pharmacopeia (USP) compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (CGMP) requirements for the manufacture of injectable products.
Full Text
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<title>Federal Register, Volume 86 Issue 240 (Friday, December 17, 2021)</title>
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[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71648-71650]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27351]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0241]
Inspection of Injectable Products for Visible Particulates; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Inspection
of Injectable Products for Visible Particulates.'' Visible particulates
in injectable products can jeopardize patient safety. This draft
guidance addresses the development and implementation of a holistic,
risk-based approach to visible particulate control that incorporates
product development, manufacturing controls, visual inspection
techniques, particulate identification, investigation, and
[[Page 71649]]
corrective actions designed to assess, correct, and prevent the risk of
visible particulate contamination. The draft guidance also clarifies
that meeting an applicable U.S. Pharmacopeia (USP) compendial standard
alone is not generally sufficient for meeting the current good
manufacturing practice (CGMP) requirements for the manufacture of
injectable products.
DATES: Submit either electronic or written comments on the draft
guidance by February 15, 2022 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> For written/paper comments submitted to the Dockets
Management 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-2021-D-0241 for ``Inspection of Injectable Products for Visible
Particulates.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 the 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; 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
the Policy and Regulations Staff (HFV-6), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., 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: Eric Dong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 6652, Silver Spring, MD 20993-0002, 240-402-4172; Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002, 240-402-7911; or Laura Huffman, Center for
Veterinary Medicine (HFV-140), Food and Drug Administration, Metro Park
North 2 (MPN2), Rm. Hotel CVM, 7500 Standish Pl., Rockville, MD 20855,
240-402-0664.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Inspection of Injectable Products for Visible
Particulates.'' Visible particulates in injectable products can
jeopardize patient safety. The draft guidance addresses a holistic
approach to visible particulate control that incorporates risk
assessment, prevention, inspection, identification, and remediation of
visible particulates in injectable products.
Adherence to FDA's CGMP requirements. as set forth in section 501
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351)
and 21 CFR parts 210 and 211 for drug, animal drug, and biological
products; 21 CFR 600.10 through 600.15 for biological products; and 21
CFR part 4 for combination products, is essential for the control of
visible particulates in injectable products. Adherence to compendial
standards can also assist manufacturers in complying with CGMP
requirements. USP General Chapter <1> Injections and Implanted Drug
Products (Parenterals)--Product Quality Tests states that ``[t]he
inspection process should be designed and qualified to ensure that
every lot of all parenteral preparations is essentially free from
visible particulates'' as defined in USP General Chapter <790> Visible
Particulates in Injections. Injectable
[[Page 71650]]
products with a USP monograph are required to meet the applicable
criteria from these USP General Chapters (see section 501(b) of the
FD&C Act). Noncompendial products should also be ``essentially free
from visible particulates'' as defined in USP General Chapter <790>.
Applying acceptance criteria, such as the criterion outlined in USP
General Chapter <790>, is an important component of the overall visible
particulate control program, but meeting these acceptance criteria
alone is not sufficient to ensure compliance with the applicable CGMP
requirements identified above, which cover a broader array of
manufacturing practices than product inspection. Full compliance with
CGMP requirements is needed to ensure the continued supply of pure,
safe, and effective injectable products.
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 ``Inspection
of Injectable Products for Visible Particulates.'' 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR parts 211, 314, and 601 have been approved
under OMB control numbers 0910-0139, 0910-0001, and 0910-0308,
respectively.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: December 14, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27351 Filed 12-16-21; 8:45 am]
BILLING CODE 4164-01-P
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