[Federal Register: October 2, 2006 (Volume 71, Number 190)]
[Notices]
[Page 57980-57981]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc06-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0443]
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 guidance for industry entitled ``Quality Systems
Approach to Pharmaceutical Current Good Manufacturing Practice
Regulations.'' This guidance explains FDA's current thinking regarding
advances that have been made in the quality and manufacturing sciences
since the current good manufacturing practice (CGMP) regulations were
issued in 1978. The 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 agency guidances 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, suite
200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label
to assist that office in processing your requests. The guidance may
also be obtained by mail by calling the CBER Voice Information System
at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
Submit written comments on the 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
.
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;
Robert Sausville, Center for Biologics Evaluation and Research
(HFM-610), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-6205;
June Liang, Center for Veterinary Medicine (HFV-143), 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 guidance for industry
entitled ``Quality Systems Approach to Pharmaceutical Current Good
Manufacturing Practice Regulations.'' This guidance was developed by
the quality systems working group formed as part of the Pharmaceutical
CGMPs for the 21st Century: A Risk Based Approach initiative (the
initiative) now the Council on Pharmaceutical Quality. The 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 initiative
was announced in August 2002 (http://www.fda.gov/cder/gmp/2ndprogressrept_plan.htm
). Among the many 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
resources available for pharmaceutical manufacturing inspections; (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 the top
priority.
The initiative's announcement stated that 21 CFR parts 210, 211,
600, and 610 are flexible and will allow the agency to embark on a
science-based risk management approach to CGMPs. This 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
regulations, the agency can help manufacturers meet the requirements of
the agency's CGMPs 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.
On October 4, 2004, FDA issued a draft of this guidance (69 FR
59256). Comments were received and considered carefully as the agency
finalized the guidance. No substantive changes were made to the final
guidance, although a number of clarifying edits were made throughout
the guidance based on the comments received. In addition, the reference
list and the graphic depicting a quality management systems approach
were updated.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on a quality systems approach to
pharmaceutical CGMP regulations. 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 regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, 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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
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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 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-16215 Filed 9-29-06; 8:45 am]
BILLING CODE 4160-01-S