[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International Conference on Harmonisation; Draft Guidance on Q9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availability of a draft guidance entitled ``Q9 Quality Risk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 The draft guidance was prepared under the auspices of the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 The draft guidance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 The draft guidance is intended to enable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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written comments on the draft guidance to the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requests for single copies of the draft guidance to the Division of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draft guidance may also be obtained by mail by calling the CBER Voice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access to the draft guidance document.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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