[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