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Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; Availability

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Food and Drug Administration, HHS.




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.


Submit written or electronic comments on agency guidances at any time.


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​dockets/​ecomments.

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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.

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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 (​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.Start Printed Page 57981

III. Electronic Access

Persons with access to the Internet may obtain the document at either​cder/​guidance/​index.htm or​ohrms/​dockets/​default.htm.

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Dated: September 7, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E6-16215 Filed 9-29-06; 8:45 am]