[Federal Register Volume 66, Number 185 (Monday, September 24, 2001)]
[Notices]
[Pages 48883-48884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23804]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Current Good Manufacturing Practice for Active Pharmaceutical 
Ingredients; Public Workshops

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshops.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a series 
of workshops to discuss the application of the International Conference 
on Harmonisation (ICH) guidance for industry entitled ``Q7A Good 
Manufacturing Practice Guidance for Active Pharmaceutical 
Ingredients,'' which will be announced in a future issue of the Federal 
Register. The workshops, which will be held in collaboration with the 
Parenteral Drug Association, the Pharmaceutical Research and 
Manufacturers of America, and the Generic Pharmaceutical Association, 
are intended to provide a regulatory perspective on current good 
manufacturing practices (CGMPs) for active pharmaceutical ingredients 
(APIs). The workshops are being scheduled to help ensure that all APIs 
meet the standards for quality and purity they purport or are 
represented to possess.

DATES: See table 1 in the SUPPLEMENTARY INFORMATION section of this 
document.

ADDRESSES: See table 1 in the SUPPLEMENTARY INFORMATION section of this 
document.

FOR FURTHER INFORMATION CONTACT:
    Erik N. Henrikson, Center for Drug

[[Page 48884]]

Evaluation and Research (HFD-320), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 301-827-0072, FAX 301-594-2202;
    Leslie Zeck, Parenteral Drug Association, 7500 Old Georgetown Rd., 
suite 620, Bethesda, MD 20814, 301-986-0293, FAX 301-986-0296, e-mail: 
http://www.pda.org;
    Alice E. Till, Pharmaceutical Research and Manufacturers of 
America, 1100 15th St. NW., Washington, DC 20005, 202-835-3400, FAX 
202-835-3597, e-mail: http://www.phrma.org; or
    Steve Bende, Generic Pharmaceutical Association, 1620 I St. NW., 
suite 800, Washington, DC 20006, 202-833-9070, FAX 202-833-9612, e-
mail: http://www.genericaccess.com.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Who Should Attend?

    This announcement is directed towards professionals involved in the 
manufacture, control, and regulation of APIs who will benefit from this 
training, including: Process/production engineers, quality assurance/
quality control and regulatory affairs professionals, auditors, agents, 
brokers, traders, distributors, repackers and relabelers of APIs, 
consultants, regulatory investigators and GMP compliance officials, and 
reviewing chemists. Other entities or individuals may also be 
interested in attending.

B. Where and When Will These Workshops Be Held?

                 Table 1.--Workshop Locations and Dates
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               Workshop Address                   Date and Local Time
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Illinois: The Allerton Crowne Plaza, 701       October 22 to 24, 2001,
 North Michigan Ave., Chicago, IL               from 9 a.m. to 5 p.m.
New Jersey: Hyatt Regency Princeton, 102       November 7 to 9, 2001,
 Carnegie Center, Princeton, NJ                 from 9 a.m. to 5 p.m.
California: The Sutton Place Hotel, 4500       February 25 to 27, 2002,
 MacArthur Blvd., Newport Beach, CA             from 9 a.m. to 5 p.m.
Puerto Rico: Caribe Hilton San Juan, Los       April 8 to 10, 2002, from
 Rosales St., San Geronimo Ground,San Juan,     9 a.m. to 5 p.m.
 PR
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C. How Can I Participate?

    You can participate in person. Anyone interested in the API 
workshops can register through any of the information contacts 
(addresses above).

D. Is There a Registration Fee for This Workshop?

    Yes, a registration fee of $995 is required for this workshop. This 
registration fee includes workshop reference materials, lunch on each 
day, and a networking reception on day 1. Government employees qualify 
for a discounted rate of $395.

E. How Can I Get Additional Information, Including Copies of This 
Document or Other Related Documents?

    Submit written requests for single copies of the Q7A guidance to 
the Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Send two self-addressed adhesive labels to assist the office 
in processing your requests. Once the notice of availability is 
announced in a future issue of the Federal Register, those with 
electronic access will be able to obtain electronic copies of the 
guidance document on the Internet at three locations: http://www.fda.gov/cder/guidance/index.htm; http://www.emea.eu.int/pdfs/human/ich/410600en.pdf; or http://www.ifpma.org/ich5q.html#gmp. The notice of 
participation form, information about the workshops, and other related 
documents are available from any of the information contacts (addresses 
above) or from the Internet at http://www.fda.gov/cder/calendar.

II. Background Information

A. Why is FDA Cosponsoring These Workshops?

    FDA is cosponsoring these 3-day workshops to provide training of 
FDA personnel alongside industry participants on the ICH Q7A CGMP 
guidance for APIs. This is the first CGMP guidance developed jointly by 
regulators and industry and is intended for use worldwide. It affects 
manufacturers who manufacturer in, or intend to supply into, the ICH 
regions (United States, Europe, Japan).

B. What Will Be Covered?

    FDA participation in these workshops will provide a regulatory 
perspective on the critical topic of the ICH guidance ``Q7A Good 
Manufacturing Practice Guidance for Active Pharmaceutical 
Ingredients.'' Attendees will hear about the intent of the Expert 
Working Group that developed the Q7A guidance and learn how to 
interpret and apply the Q7A guidance, including special sections on 
APIs manufactured by cell culture/fermentation, and APIs for use in 
clinical trials.

    Dated: September 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-23804 Filed 9-21-01; 8:45 am]
BILLING CODE 4160-01-S