[Federal Register Volume 74, Number 66 (Wednesday, April 8, 2009)]
[Notices]
[Pages 15990-15991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7875]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0370] (formerly Docket No. 2007-D-0266)


International Conference on Harmonisation; 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 guidance entitled ``Q10 Pharmaceutical Quality 
System.'' The guidance was prepared under the auspices of the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). The guidance 
describes a model for an effective quality management system for the 
pharmaceutical industry, referred to as the Pharmaceutical Quality 
System. The 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 ICH guidances on ``Q8 Pharmaceutical Development'' and ``Q9 
Quality Risk Management.''

DATES: Submit written or electronic comments on agency guidance 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, 10903 New Hampshire Ave., 
Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or the Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, 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. 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.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Joseph C. Famulare, Center for Drug 
Evaluation and Research (HFD-300), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, rm. 5266, Silver Spring, MD 20993-0002, 
301-796-3100;
    Christopher Joneckis, Center for Biologics Evaluation and Research 
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, suite 200, 
Rockville, MD 20852, 301-827-0373; 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 the IFPMA, as well as observers from the World 
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of July 13, 2007 (72 FR 38604), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``Q10 Pharmaceutical Quality System.'' The notice gave 
interested persons an opportunity to submit comments by October 11, 
2007.
    After consideration of the comments received and revisions to the 
guidance,

[[Page 15991]]

a final draft of the guidance was submitted to the ICH Steering 
Committee and endorsed by the three participating regulatory agencies 
in June 2008.
    The ICH Q10 guidance provides recommendations for a comprehensive 
approach to an effective pharmaceutical quality system that is based on 
ISO concepts, includes applicable GMP regulations and complements ICH 
``Q8 Pharmaceutical Development'' and ``Q9 Quality Risk Management.'' 
The guidance describes a model for a pharmaceutical quality system that 
can be implemented throughout the different stages of a product 
lifecycle. Much of the content of the guidance applicable to 
manufacturing sites is currently specified by regional GMP 
requirements. The guidance is not intended to create any new 
expectations beyond current regulatory requirements.
    The ICH Q10 guidance demonstrates industry and regulatory 
authorities' support of an effective pharmaceutical quality system to 
enhance the quality and availability of medicines around the world in 
the interest of public health. Implementation of the provisions of the 
guidance throughout the product lifecycle should facilitate innovation 
and continual improvement and strengthen the link between 
pharmaceutical development and manufacturing activities.
    In 2006, FDA published a guidance for industry entitled ``Quality 
Systems Approach to Pharmaceutical Current Good Manufacturing Practice 
Regulations'' (October 2, 2006, 71 FR 57980). The 2006 guidance 
describes the key elements of a robust quality systems model and shows 
how implementation of such a model is one way to comply with FDA's 
current good manufacturing practice (CGMP) regulations. The 2006 
guidance shows the correlation of ICH Q10 quality system components to 
FDA's CGMP regulations.
    The ICH Q10 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 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 comments on the 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.

    Dated: March 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7875 Filed 4-7-09; 8:45 am]
BILLING CODE 4160-01-S