Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment Addendum; Availability, 19495 [2013-07432]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Page 19495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07432]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0295]


Draft Guidance for Industry on Scale-Up and Post-Approval 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availability of a scale-up and post-approval changes (SUPAC) draft 
guidance for industry entitled ``SUPAC: Manufacturing Equipment 
Addendum.'' This revised draft document combines and supersedes ``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 has now 
revised the draft manufacturing equipment addenda to remove the 
equipment examples and to clarify the types of processes being 
referenced.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance and on any other part of the SUPAC guidance series, submit 
either electronic or written comments on the draft guidance by July 1, 
2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to https://www.regulations.gov.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: Jon Clark, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-2400.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a SUPAC draft guidance for 
industry entitled ``SUPAC: Manufacturing Equipment Addendum.'' This 
revised draft document combines and supersedes 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'' (https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070636.pdf), (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'' (https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070640.pdf), 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'' (https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070930.pdf).
    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. These efforts 
will also be considered part of the finalization process for this 
guidance.
    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 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 https://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 https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: March 26, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07432 Filed 3-29-13; 8:45 am]
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