[Federal Register Volume 62, Number 104 (Friday, May 30, 1997)]
[Notices]
[Page 29355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0200]


Control of Pharmaceutical Production; Out-of-Specification 
Guidance for Laboratory Testing; Notice of Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting sponsored by the Office of Regulatory Affairs (ORA), FDA. This 
meeting will involve representatives from ORA's Division of Field 
Science, the Center for Drug Evaluation and Research, and other 
representatives from FDA. The topic of this public meeting is out-of-
specification (OOS) laboratory test results used in pharmaceutical 
production. This meeting will provide guidance in appropriate 
evaluation of, and response to, out-of-specification test results.

DATES: The public meeting will be held on Friday, June 20, 1997, from 
10 a.m. to 12 m.

ADDRESSES: The meeting will be held at the Westin Rio Mar Beach Resort, 
6000 Rio Mar Blvd., Rio Grande, PR 00745. A conference room will be 
announced in the hotel lobby before the session.

FOR FURTHER INFORMATION CONTACT: Len P. Valenti, Office of Regulatory 
Affairs, Division of Field Science (HFC-141), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12-41, Rockville, MD 20857, 301-
443-3320, FAX 301-443-6388.
    Questions related to this meeting should be directed to Len P. 
Valenti or Richard A. Baldwin, Director, Division of Field Sciences 
(address above) or by calling 301-443-3320, between 8 a.m. and 4:30 
p.m.
Supplementary Information: 
    The purpose of this meeting is to continue a dialogue with members 
of trade, technical, and professional organizations, and other 
interested persons in order to discuss issues associated with the 
pharmaceutical laboratory practices and procedures.
    On November 20, 1996, FDA held a public meeting to informally 
address and outline ways to discuss problems associated with the 
development and monitoring of pharmaceutical products. The meeting 
explored issues of concern to the agency and industry laboratories. As 
a result of the meeting, industry members asked FDA to provide guidance 
in two control aspects of pharmaceutical production: (1) Evaluating OOS 
test results, and (2) system suitability requirements in measuring 
performance of a chromatographic system.
    Interested persons who are unable to attend this meeting may 
contact the Division of Field Science (address above) regarding plans 
for a second meeting on this topic. A second OOS seminar is currently 
being planned for late August or early September 1997, in the Mid-
Atlantic region. A Federal Register notice will be issued to notify all 
interested parties to announce its availability.
    In addition to the OOS meeting in Rio Grande, PR, a system 
suitability workshop, scheduled for Monday, June 9, 1997, at the 
Hoffman-La Roche facility in Nutley, NJ was announced in the Federal 
Register of May 13, 1997 (62 FR 26320).

    Dated: May 23, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-14141 Filed 5-29-97; 8:45 am]
BILLING CODE 4160-01-F