[Federal Register: September 5, 2003 (Volume 68, Number 172)]
[Page 52782-52783]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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Draft Guidance for Industry on ``Sterile Drug Products Produced 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.


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availability of a draft guidance for industry entitled ``Sterile Drug 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance document.

    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.


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to formal issuance of a draft guidance for public comment.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issuing the draft guidance, which when finalized will revise the 1987 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]