[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Draft Guidance for Industry; Container and Closure Integrity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availability of the draft guidance entitled ``Guidance for Industry: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 The draft
guidance is intended to provide recommendations and offer alternative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 The draft guidance applies only to the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ADDRESSES: Submit written comments on the draft guidance to the Dockets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for single copies of the draft guidance entitled ``Guidance for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