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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)

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# 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,                           ( print 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