[Federal Register Volume 71, Number 190 (Monday, October 2, 2006)]
[Notices]
[Pages 57980-57981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16215]



[[Page 57980]]

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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