[Federal Register: August 8, 2005 (Volume 70, Number 151)]
[Notices]               
[Page 45722-45723]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au05-96]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0288]

 
International Conference on Harmonisation; Draft Guidance on Q9 
Quality Risk Management; 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availability of a draft guidance entitled ``Q9 Quality Risk 
Management.'' The draft guidance was prepared under the auspices of the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). The draft guidance 
provides principles and examples of tools for quality risk management 
that can be applied to all aspects of pharmaceutical quality throughout 
the lifecycle of drug substances, drug products, and biological and 
biotechnological products. The draft guidance is intended to enable 
regulators and industry to make more effective and consistent risk-
based decisions.

DATES: Submit written or electronic comments on the draft guidance by 
October 7, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written comments on the draft guidance to the 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. 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requests for single copies of the draft guidance to the Division of 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 (CBER), Food and 
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The 
draft guidance may also be obtained by mail by calling the CBER Voice 
Information System at 1-800-835-4709 or 301-827-1800. Send two self-
addressed adhesive labels to assist the office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: David J. Horowitz, Center for Drug 
Evaluation and Research (HFD-300), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-8910; Anna M. Flynn, Center 
for Biologics Evaluation and Research (HFM-610), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6201; 
Diana J. Kolaitis, Office of Regulatory Affairs (HFR-NE1), Food and 
Drug Administration,

[[Page 45723]]

158-15 Liberty Ave., Jamaica, NY 11433, 718-662-5416; or H. Gregg 
Claycamp, Center for Veterinary Medicine (HFV-102), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-4354.
    Regarding the ICH: Michelle Limoli, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4480.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of regulatory requirements. FDA has 
participated in many meetings designed to enhance harmonization and is 
committed to seeking scientifically based harmonized technical 
procedures for pharmaceutical development. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. FDA also seeks input from 
consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and the United States. The six ICH sponsors are the European 
Commission; the European Federation of Pharmaceutical Industries 
Associations; the Japanese Ministry of Health, Labour, and Welfare; the 
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug 
Evaluation and Research and Biologics Evaluation and Research, FDA; and 
the Pharmaceutical Research and Manufacturers of America. The ICH 
Secretariat, which coordinates the preparation of documentation, is 
provided by the International Federation of Pharmaceutical 
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization, Health Canada, and the European Free Trade Area.
    During the July 2003 ICH meeting in Brussels, agreement was reached 
on a common vision and approach for developing an international plan 
for a harmonized pharmaceutical quality system that would be applicable 
across the lifecycle of a product. This plan emphasizes an integrated 
approach to review (assessment) and inspection based on scientific risk 
management. One aspect of the plan was the establishment of an expert 
working group to develop guidance for quality risk management.
    In March 2005, the ICH Steering Committee agreed that a draft 
guidance entitled ``Q9 Quality Risk Management'' should be made 
available for public comment. The draft guidance is the product of the 
Quality Risk Management Expert Working Group of the ICH. Comments about 
this draft will be considered by FDA and the ICH expert working group.
    The draft guidance provides principles and examples of tools for 
quality risk management that can be applied to all aspects of 
pharmaceutical quality throughout the lifecycle of drug substances, 
drug products, and biological and biotechnological products. These 
quality risk management approaches apply to the development, 
manufacturing, distribution, inspection, and submission/review 
processes, including the use of raw materials, solvents, excipients, 
and packaging and labeling materials. The draft guidance is intended to 
support other ICH quality documents, to complement existing quality 
practices and standards, and to enable regulators and industry to make 
more effective and consistent risk-based decisions.
    This document supports FDA's ``Pharmaceutical Current Good 
Manufacturing Practices for the 21st Century'' initiative, which was 
intended to bring a 21st century focus to the regulation of 
pharmaceutical manufacturing and product quality. One objective of this 
initiative is to encourage the implementation of risk-based approaches 
that focus both industry and agency attention on critical areas.
    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 Q9 quality 
risk management. 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. 
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. The draft guidance and received 
comments may be seen 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 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, 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://www.fda.gov/cber/reading.htm.
v/cber/reading.htm.

    Dated: August 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-15546 Filed 8-5-05; 8:45 am]

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