[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Pages 59255-59256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22206]
[[Page 59256]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0443]
Draft Guidance for Industry on Quality Systems Approach to
Pharmaceutical Current Good Manufacturing Practice Regulations;
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availability of a draft guidance for industry entitled ``Quality
Systems Approach to Pharmaceutical Current Good Manufacturing Practice
Regulations.'' The draft guidance describes the key elements of a
robust quality systems model and shows how persons implementing such a
model can achieve compliance with the CGMP regulations.
DATES: Submit written or electronic comments on the draft guidance by
December 3, 2004. 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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; 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draft guidance to the Division of Dockets Management (HFA-305), Food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access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Monica Caphart, Center for Drug Evaluation and Research (HFD-320),
Food and Drug Administration, 11919 Rockville Pike, Rockville, MD
20852, 301-827-9047; or
Robert Sausville, Center for Biologics Evaluation and Research
(HFM-624), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-6201; or
June Liang, Center for Veterinary Medicine (HFV-12), Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-8789;
or
Patricia Maroney-Benassi, Office of Regulatory Affairs (HFC-240),
15800 Crabbs Branch Way, Rockville MD 20855, 240-632-6819.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Quality Systems Approach to Pharmaceutical Current Good
Manufacturing Practice Regulations.'' The draft guidance illustrates
where FDA can harmonize across agency centers and with other non-U.S.
pharmaceutical quality management requirements. This draft guidance was
developed by the quality systems group formed as part of the CGMP for
the 21st Century initiative. The draft guidance is intended to
encourage the use of modern quality management system principles by the
regulated industry and foster innovation and continuous improvements in
pharmaceutical manufacturing.
The Pharmaceutical CGMPs for the 21st Century: A Risk Based
Approach initiative was announced in August 2002 (http://www.fda.gov/cder/gmp/2ndProgressRept_Plan.htm). Among the many CGMP issues
identified at that time were: (1) The increase in the number of
pharmaceutical products and in the role of medicines in health care;
(2) the decrease in the frequency of FDA manufacturing inspections
resulting from fewer available resources; (3) FDA's increasing
experience with, and lessons learned from, various approaches to the
regulation of product quality; (4) advances in the pharmaceutical
sciences and manufacturing technologies; (5) the increasing application
of biotechnology in drug discovery and manufacturing; (6) advances in
the science and management of quality; and (7) the globalization of the
pharmaceutical industry.
At the outset, the agency established a set of guiding principles
for the initiative:
Maintain a risk-based orientation;
Policies and standards must be science based;
The agency's orientation must be toward integrated quality
systems;
International cooperation is very important; and
Protection of the public health must remain top priority.
The initiative's announcement stated that 21 CFR parts 210, 211,
and parts 600 and 610 are flexible and will allow the agency to embark
on a science-based risk management approach to CGMPs. This draft
guidance, developed by a cross-center working group established by the
initiative, is key in achieving the agency's goals. By showing how
modern quality systems approaches relate to the existing CGMP
regulation, the agency can help manufacturers meet the requirements of
the agency's CGMP while using a robust quality systems approach to the
production of human and animal medical products. Such a comprehensive
approach should foster flexibility and allow for continued innovation,
while maintaining the principles of the CGMP regulations.
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 this topic.
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
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.
Two paper copies of mailed comments are to be submitted, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. The draft guidance and received comments are available for
public examination 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 document 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. 04-22206 Filed 9-29-04; 1:51 pm]
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