[Federal Register Volume 72, Number 134 (Friday, July 13, 2007)]
[Notices]
[Pages 38604-38605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13667]



[[Page 38604]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0266]


International Conference on Harmonisation; Draft Guidance on Q10 
Pharmaceutical Quality System; 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availability of a draft guidance entitled ``Q10 Pharmaceutical Quality 
System.'' The draft guidance was prepared under the auspices of the 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 The draft guidance 
describes a model for an effective quality management system for the 
pharmaceutical industry, referred to as the Pharmaceutical Quality 
System. The draft guidance applies to drug substances and drug 
products, including biotechnology and biological products, throughout 
the product lifecycle. The draft guidance is intended to provide a 
comprehensive approach to an effective pharmaceutical quality system 
that is based on International Organization for Standardization (ISO) 
concepts, includes applicable good manufacturing practice (GMP) 
regulations, and complements the ICH guidances on ``Q8 Pharmaceutical 
Development'' and ``Q9 Quality Risk Management.''

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by October 11, 2007.

ADDRESSES:  Submit written comments on the draft guidance to the 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://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requests for single copies of the draft guidance to the Division of 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, suite 200N, Rockville, MD 
20852-1448. The guidance may also be obtained by mail by calling CBER 
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: Joseph C. Famulare, Center for Drug 
Evaluation and Research (HFD-300), Food and Drug Administration, 11919 
Rockville Pike, Rockville, MD 20852, 301-827-8910; Christopher 
Joneckis, Center for Biologics Evaluation and Research (HFM-1), Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-
435-5681; or Diana Amador-Toro, Office of Regulatory Affairs (HFR-
CE350), Food and Drug Administration, 10 Waterview Blvd., Parsippany, 
NJ 07054, 973-331-4915.
    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 IFPMA, as well as observers from the World Health 
Organization, Health Canada, and the European Free Trade Area.
    In May 2007, the ICH Steering Committee agreed that a draft 
guidance entitled ``Q10 Pharmaceutical Quality System'' should be made 
available for public comment. The draft guidance is the product of the 
Quality Expert Working Group of the ICH. Comments about this draft will 
be considered by FDA and the Quality Expert Working Group.
    The draft guidance provides guidance on a comprehensive approach to 
an effective pharmaceutical quality system that is based on ISO 
concepts, includes applicable GMP regulations, and complements the ICH 
guidances on ``Q8 Pharmaceutical Development'' and ``Q9 Quality Risk 
Management.'' The draft guidance describes a model for a pharmaceutical 
quality system that can be implemented throughout the different stages 
of a product lifecycle.
    The model demonstrates industry and regulatory authorities' support 
of an effective pharmaceutical quality system to enhance the quality, 
safety, and availability of medicines around the world in the interest 
of public health. Implementation of the Pharmaceutical Quality System 
throughout the product lifecycle should facilitate innovation and 
continual improvement, promote the use of scientific and risk 
management principles, and strengthen the link between pharmaceutical 
development and manufacturing activities.
    The draft guidance applies to drug substances and drug products, 
including biotechnology and biological products, throughout the product 
lifecycle. Much of the content of the draft guidance applicable to 
manufacturing sites is currently specified by regional GMP 
requirements. The draft guidance is not intended to create any new 
expectations beyond current regulatory requirements. Consequently, 
content of the guidance that is additional to current GMP requirements 
is optional.

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    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 this topic. 
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. 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://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/reading.htm.

    Dated: July 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13667 Filed 7-12-07; 8:45 am]
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