[Federal Register: October 4, 2004 (Volume 69, Number 191)]
[Notices]               
[Page 59256]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc04-78]                         


[[Page 59256]]

-----------------------------------------------------------------------

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Draft Guidance for Industry on Quality Systems Approach to 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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry entitled ``Quality 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 The draft guidance describes the key elements of a 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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draft guidance to the Division of Dockets Management (HFA-305), Food 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://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access to the draft guidance document.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:
    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://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: September 28, 2004.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22206 Filed 9-29-04; 1:51 pm]

BILLING CODE 4160-01-S