[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replaces the draft guidance of the same name that combined and 
superseded ``SUPAC IR/MR: Immediate Release and Modified Release Solid 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replaces the draft guidance of the same name that superseded the 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