Document ID: FDA-2008-D-0060-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products; Availability
Posted Date: 2008-02-25T05:00Z

[Federal Register: February 25, 2008 (Volume 73, Number 37)]
[Notices]               
[Page 10035-10036]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe08-79]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0060] (formerly Docket No. 1998D-0021)

 
Guidance for Industry: Container and Closure System Integrity 
Testing in Lieu of Sterility Testing as a Component of the Stability 
Protocol for Sterile Products; 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 document entitled ``Guidance for Industry: Container 
and Closure System Integrity Testing in Lieu of Sterility Testing as a 
Component of the Stability Protocol for Sterile Products,'' dated 
February 2008. The guidance document provides recommendations to 
sponsors for using methods other than sterility testing to confirm the 
integrity of container and closure systems as part of stability testing 
for sterile biological products, human and veterinary drugs, and

[[Page 10036]]

medical devices. The guidance document does not apply to sterility 
testing methods for product sterility testing prior to release, as 
container and closure system integrity tests cannot demonstrate a 
product's initial sterility. The guidance announced in this notice 
finalizes the draft guidance entitled ``Container and Closure Integrity 
Testing in Lieu of Sterility Testing as a Component of the Stability 
Protocol for Sterile Products,'' dated January 1998.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of theguidance to 
the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and 
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852-1448; or to the Division of Drug Information (HFD-240), Center 
for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, 
MD 20857; or to the Communications Staff (HFV-12), Center for 
Veterinary Medicine (CVM), Food and Drug Administration, 7519 Standish 
Pl., Rockville, MD 20855; or to the Division of Small Manufacturers, 
International, and Consumer Assistance (HFZ-220), Center for Devices 
and Radiological Health (CDRH), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. The guidance may also be obtained by 
calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210,or
    David Hussong, Center for Drug Evaluation and Research (HFD-805), 
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, 
MD 20993-0002, 301-796-1228,or
    Geetha J. Jayan, Center for Devices and Radiological Health (HFZ-
470), Food and Drug Administration, 9200 Corporate Blvd, Rockville, MD 
20850, 240-276-3747, or
    Mai Huynh, Center for Veterinary Medicine (HFV-140), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6963.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance document entitled 
``Guidance for Industry: Container and Closure System Integrity Testing 
in Lieu of Sterility Testing as a Component of the Stability Protocol 
for Sterile Products,'' dated February 2008. The guidance document 
provides information to sponsors who propose using alternative methods 
to sterility testing to confirm container and closure integrity for 
sterile biological products, human and veterinary drugs, and medical 
devices throughout a product's dating period. The guidance document is 
applicable only to stability testing, a means of confirming expiration 
dating. The alternatives described in the guidance document are not 
offered as a replacement for sterility testing prior to product 
release, as container and closure system integrity tests cannot 
demonstrate a product's initial sterility.
    In the Federal Register of January 28, 1998 (63 FR 4272), FDA 
announced the availability of the draft guidance entitled ``Container 
and Closure Integrity Testing in Lieu of Sterility Testing as a 
Component of the Stability Protocol for Sterile Products,'' dated 
January 1998. FDA received numerous comments on the draft guidance and 
those comments were considered as the guidance was finalized. Editorial 
changes were made to improve clarity. This guidance document was 
prepared jointly by CBER, CDER, CVM, and CDRH.
    The guidance document is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance document 
represents the agency's current thinking on this topic. 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. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These 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. 3501-3520). The 
collections of information in 21 CFR 211.166 have been approved under 
OMB control number 0910-0139; the collections of information in 21 CFR 
314.70 have been approved under OMB control number 0910-0001; the 
collections of information in 21 CFR 514.8 have been approved under OMB 
control number 0910-0032; the collections of information in 21 CFR 
601.12 have been approved under OMB control number 0910-0338; the 
collections of information in 21 CFR 809.10 have been approved under 
OMB control number 0910-0485; the collections of information in 21 CFR 
814.39 have been approved under OMB control number 0910-0231; and the 
collections of information in 21 CFR 820.75 have been approved under 
OMB control number 0910-0073.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the guidance. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except that individuals may 
submit one paper copy. Comments are to be identified with the docket 
number found in brackets in the heading of this document. A copy of the 
guidance and received comments are available for public examination in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/cder/
guidance/index.htm, or http://www.fda.gov/cdrh/guidance.html, or http:/
/www.fda.gov/cvm/guidance/published.htm, or http://www.fda.gov/ohrms/
dockets/default.htm.

    Dated: February 12, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3487 Filed 2-22-08; 8:45 am]

BILLING CODE 4160-01-S