[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Pages 59258-59259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22207]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 2003D-0382]
Food and Drug Administration
Guidance for Industry on Sterile Drug Products Produced by
Aseptic Processing--Current Good Manufacturing Practice
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 guidance for industry entitled ``Sterile Drug
Products Produced by Aseptic Processing--Current Good Manufacturing
Practice.'' This guidance explains FDA's current thinking on
manufacturing of sterile drug products produced by aseptic processing
in the context of complying with certain sections of the current good
manufacturing practice (CGMP) regulations for drug and biological
products. This guidance is issued with the goal of providing clear and
consistent communication of regulatory expectations to promote
voluntary compliance with current FDA requirements.
DATES: General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the 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; or 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. 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draft guidance to the Division of Dockets Management (HFA-305), Food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://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Richard Friedman, Center for Drug Evaluation and Research (HFD-
320), Food and Drug Administration, 11919 Rockville Pike, Rockville, MD
20852, 301-827-9031; 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
Robert Coleman, Office of Regulatory Affairs (HFC-240), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 404-253-
1295.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Sterile Drug Products Produced by Aseptic Processing--
Current Good Manufacturing Practice.'' This guidance explains FDA's
current thinking on manufacturing of sterile drug products produced by
aseptic processing in the context of complying with certain sections of
the CGMP regulations for drug and biological products (21 CFR parts
210, 211, and 600 through 680, respectively).
In the Federal Register of September 5, 2003 (68 FR 52782), FDA
announced the availability of a draft guidance entitled ``Sterile Drug
Products Produced by Aseptic Processing-- Current Good Manufacturing
Practice.'' The draft guidance was finalized after consideration of
received public comments. Consistent with the objectives of FDA's CGMPs
for the 21st Century initiative, this guidance provides updated
information regarding CGMP expectations for aseptic processing
facilities, reflects the latest science in the area of sterile drug
quality, and promotes innovations in manufacturing that achieve
increased sterility assurance. Through this guidance, FDA hopes to
facilitate a higher assurance of process consistency and promote better
contamination prevention practices.
Sterile drug products are a high priority in FDA's risk-based
inspectional program. These drug products are generally of high
therapeutic significance. Clarifying relevant regulatory standards for
sterile drug products will help reduce the incidence of manufacturing
problems with this class of pharmaceuticals, thus facilitating the
ready availability of these therapeutically significant pharmaceuticals
and avoiding drug shortages.
This guidance document is the product of extensive public input.
FDA first published a preview of its current thinking in the form of a
concept paper on September 23, 2003. We presented our CGMP approach 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, an aseptic processing working
group was formed under Product Quality Research Institute (PQRI) to
address these issues. The working group, composed of 41 prominent
aseptic processing experts from industry, academia, and FDA, prepared
technical recommendations on the guidance document. 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
(www.pqri.org).\1\ The draft guidance was published on September 3,
2003.
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\1\ FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.
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The advisory committee and PQRI Working Group recommendations
provided valuable contributions and many of these recommendations have
been adopted in the guidance.
II. Comments Received on the Draft Guidance
A number of comments were received on the draft guidance, most of
which concerned the need to further enhance the precision of guidance
provided on certain topics. As a result, many clarifying changes were
made. Major changes include the revision of the Sterility Testing
section of the guidance to clearly emphasize and reference the United
States Pharmacopeial Sterility Test <71>. In the guidance, table 1
entitled ``Air Classifications,'' which
[[Page 59259]]
summarizes clean area air classifications and recommended
microbiological action levels, has been modified to acknowledge that
alternate action levels can be justified depending on the method of
analysis used. Further clarifications have been made regarding process
simulations. In addition, the guidance recommends ``building quality
into products'' through science-based facility, equipment, and systems
design for sterile drug manufacture. We underscore our encouragement of
alternate approaches and innovations to achieve increased sterility
assurance.
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the agency's current thinking. 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 the approach satisfies the
requirements of the applicable statute and regulations.
III. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The
collection of information in this guidance was approved under OMB
control number 0910-0139, until August 31, 2005.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: September 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22207 Filed 9-29-04; 2:14 pm]
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