[Federal Register: September 5, 2003 (Volume 68, Number 172)]
[Notices]
[Page 52782-52783]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se03-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0382]
Draft Guidance for Industry on ``Sterile Drug Products Produced
by Aseptic Processing''
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; availability.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Sterile Drug
Products Produced by Aseptic Processing.'' FDA expects that enhanced
compliance in the area of sterile drug manufacture will lead to a
higher assurance of process consistency and minimize supply problems
with therapeutically necessary drugs.
DATES: Submit written or electronic comments on the draft guidance by
November 4, 2003. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the draft guidance to the Division of Dockets Management (HFA-305),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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Richard Friedman, Center for Drug Evaluation and Research (HFD-
320), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-9041; or
Robert Sausville, Center for Biologics Evaluations and Research
(HFM-624), Food and Drug Administration,1401 Rockville Pike, Rockville,
MD 20852-1448, 301-827-6201; or
Bob Coleman, Office of Regulatory Affairs (HFC-240), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 404-253-4295.
SUPPLEMENTARY INFORMATION:
I. Background
On September 27, 2002, FDA released a ``concept paper'' regarding
aseptic processing (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.fda.gov/cder/dmpq) to solicit early input prior
to formal issuance of a draft guidance for public comment. We are now
issuing the draft guidance, which when finalized will revise the 1987
industry guidance ``Sterile Drug Products Produced by Aseptic
Processing.'' FDA's objective in revising the 1987 guidance is to issue
a document that meets the following goals: (1) Provides greater clarity
by including updated information regarding current good manufacturing
practice (CGMP) expectations for aseptic processing facilities, and (2)
reflects the latest scientific developments in this area of sterile
drug quality. The 1987 guidance is being revised as part of the
agency's broad effort ``Pharmaceutical CGMPs for the 21st Century: A
Risk-Based Approach,'' announced in August 2002.
In preparation for issuing this draft guidance, we presented our
CGMP concept for aseptic processing at the Advisory Committee for
Pharmaceutical Science on October 22, 2002. At this meeting, the
concept paper was discussed in a public forum and critiqued by the
advisory committee's members as well as a panel of invited aseptic
processing experts. The advisory committee meeting yielded a number of
issues that provided impetus for further discussion. In December 2002,
a working group under the Product Quality Research Institute (PQRI) was
formed to address these issues. The PQRI working group, comprising 41
aseptic processing experts from industry, academia, and FDA,
recommended 8 specific text clarifications on the concept paper and 10
detailed recommendations on various issues of aseptic processing. The
PQRI Steering Committee forwarded the working group's final report to
FDA on March 19, 2003, and it was subsequently posted on PQRI's Web
site http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.pqri.org. (FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.) We have taken comments from the
Advisory Committee and PQRI Working Group into consideration in
converting the Concept Paper into this draft 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 the
manufacturing of sterile drugs produced by aseptic processing. It does
[[Page 52783]]
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 to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Submit a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
or two copies of any mailed comments, except that
individuals may submit one copy. The draft guidance and the comments
submitted to the docket may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
Dated: August 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-22576 Filed 9-3-03; 10:00 am]
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