[Federal Register Volume 63, Number 18 (Wednesday, January 28, 1998)]
[Notices]
[Pages 4272-4273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2021]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0021]


Draft Guidance for Industry; Container and Closure Integrity 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availability of the draft guidance entitled ``Guidance for Industry: 
Container and Closure Integrity Testing in Lieu of Sterility Testing as 
a Component of the Stability Protocol for Sterile Products.'' The draft 
guidance is intended to provide recommendations and offer alternative 
methods for sterility testing to confirm the integrity of container and 
closure systems for sterile biological products, human and veterinary 
drugs, and medical devices. The draft guidance applies only to the 
replacement of the sterility test with an appropriate container and 
closure integrity test in the stability protocol, and it is not offered 
as a replacement for sterility testing for product release.

DATES: Written comments may be provided at any time, however, to ensure 
comments are considered for the next revision they should be submitted 
by March 30, 1998.
ADDRESSES: Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Submit written requests 
for single copies of the draft guidance entitled ``Guidance for 
Industry: Container and Closure Integrity Testing in Lieu of Sterility 
Testing as a Component of the Stability Protocol for Sterile Products'' 
to the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. The document may also be obtained by mail by calling the CBER 
Voice Information System at 1-800-835-4709 or 301-827-1800, or by fax 
by calling the FAX Information System at 1-888-CBER-FAX or 301-827-
3844. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Guidance for Industry: Container and Closure Integrity Testing in 
Lieu of Sterility Testing as a Component of the Stability Protocol for 
Sterile Products.'' The draft guidance provides general information on 
procedures and practices that should be considered when a manufacturer 
selects alternative methods to confirm sterility during stability 
studies of sterile biological products, human and veterinary drugs, and 
medical devices.
    All sterile products are required to have adequate container and 
closure integrity and to remain free from contamination throughout the 
product's entire dating period. As a consequence

[[Page 4273]]

of the limitations of sterility testing, FDA has determined that 
alternative methods are available that may more reliably confirm the 
integrity of the container and closure system in the final form 
throughout the entire dating period.
    The draft guidance was prepared jointly by the following Centers: 
Center for Biologics Evaluation and Research (CBER), Center for Drug 
Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), 
and Center for Devices and Radiological Health (CDRH). At the request 
of CBER's Stability and Formulation Committee, representatives from the 
Centers met on May 19, 1994, to discuss sterility testing as a 
component of the stability protocol. The ability of containers/
packaging to maintain sterility should be proven for all sterile 
products.
    As with other guidance documents, FDA does not intend this document 
to be all-inclusive and cautions that not all information may be 
applicable to all situations. The document is intended to provide 
information and does not set forth requirements. Alternative approaches 
may be warranted in specific situations, and certain aspects may not be 
applicable to all situations. If a manufacturer believes that the 
procedure described in the draft guidance is inapplicable to a 
particular method and other procedures are appropriate for FDA's 
consideration, the manufacturer may wish to discuss the matter further 
with the agency to prevent expenditure of money and effort on 
activities that later may be determined to be unacceptable by FDA. FDA 
will continue to review alternative methods on a case-by-case basis.
    The draft guidance represents the agency's current thinking on 
container and closure integrity testing during stability monitoring for 
sterile products. 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 statute, regulations, or both. The draft guidance document 
is being distributed for comment purposes only and is not intended for 
implementation at this time.

II. Request for Comments

    Interested persons may, at any time, submit written comments to the 
Dockets Management Branch (address above) regarding this draft guidance 
document. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments and requests for copies are 
to be identified with the docket number found in the brackets in the 
heading of this document. A copy of the draft guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    In order to receive the ``Guidance for Industry: Container and 
Closure Integrity Testing in Lieu of Sterility Testing as a Component 
of the Stability Protocol for Sterile Products'' via your fax machine, 
call the FAX Information System at 1-888-CBER-FAX or 301-827-3844.
     Persons with access to the Internet may obtain the draft guidance 
document by using the World Wide Web (WWW). For WWW access, connect to 
CBER at ``http://www.fda.gov/cber/guidelines.htm''. Received comments 
will be considered in determining whether further revision of the draft 
guidance document is warranted.

    Dated: January 21, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-2021 Filed 1-27-98; 8:45 am]
BILLING CODE 4160-01-F