[Federal Register Volume 79, Number 231 (Tuesday, December 2, 2014)]
[Notices]
[Page 71435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28256]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0295]
Guidance for Industry on Scale-Up Post-Approval Changes:
Manufacturing Equipment Addendum; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a scale-up and post-approval changes (SUPAC) guidance
for industry entitled ``SUPAC: Manufacturing Equipment Addendum.'' This
replaces the draft guidance of the same name that combined and
superseded ``SUPAC IR/MR: Immediate Release and Modified Release Solid
Oral Dosage Forms: Manufacturing Equipment Addendum,'' published on
January 1, 1999; and ``SUPAC-SS: Nonsterile Semisolid Dosage Forms;
Manufacturing Equipment Addendum,'' published as a draft on December 1,
1998. FDA revised the draft manufacturing equipment addenda to remove
the equipment examples and to clarify the types of processes being
referenced.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Akm Khairuzzaman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3886.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a SUPAC guidance for industry
entitled ``SUPAC: Manufacturing Equipment Addendum.'' This guidance
replaces the draft guidance of the same name that superseded the
following guidances for industry: (1) ``SUPAC IR/MR: Immediate Release
and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment
Addendum,'' published on January 1, 1999, and (2) ``SUPAC-SS:
Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,
``published as draft on December 1, 1998. When published, these
guidances included tables that listed specific equipment that were
misinterpreted as a list of FDA required equipment. In addition, FDA is
concerned that the equipment addenda may no longer reflect current
practices and may be limiting, instead of encouraging, manufacturers to
continually evaluate and update practices. FDA has removed the tables
listing specific manufacturing equipment from these guidances and
combined them into a single addendum. FDA has also made some changes to
clarify the types of processes being referenced.
This guidance should be used with the following guidances for
industry to determine what documentation should be submitted to FDA
regarding equipment changes: (1) ``SUPAC-IR: Immediate Release Solid
Oral Dosage Forms--Scale-Up and Post-Approval Changes: Chemistry,
Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo
Bioequivalence Documentation,'' (2) ``SUPAC-MR: Modified Release Solid
Oral Dosage Forms Scale-Up and Post-Approval Changes: Chemistry,
Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo
Bioequivalence Documentation,'' and (3) ``SUPAC-SS: Nonsterile
Semisolid Dosage Forms, Scale-Up and Post Approval Changes: Chemistry
Manufacturing and Controls; In Vitro Release Testing and In Vivo
Bioequivalence Documentation.''
As part of a greater effort, FDA is thoroughly reviewing the SUPAC
guidance series to determine how these guidances fit with current
manufacturing practices, including, but not limited to, risk-based
assessment approaches and quality by design principles. This guidance
is being issued consistent with FDA's good guidance practices
regulation (21 CFR 10.115). This guidance represents the Agency's
current thinking on manufacturing equipment. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: November 25, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28256 Filed 12-1-14; 8:45 am]
BILLING CODE 4164-01-P