[Federal Register Volume 63, Number 189 (Wednesday, September 30, 1998)]
[Notices]
[Pages 52276-52277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26084]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0777]


Draft Guidance for Industry on Investigating Out of Specification 
(OOS) Test Results for Pharmaceutical Production; 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availability of a draft guidance document entitled ``Investigating Out 
of Specification (OOS) Test Results for Pharmaceutical Production.'' 
The purpose of this draft guidance document is to provide guidance to 
the pharmaceutical industry on what to do when analytical test results 
fall outside of specifications (OOS) during pharmaceutical production.

DATES: Written comments on the draft guidance document may be submitted 
by November 30, 1998. General comments on the agency guidance documents 
are welcome at any time.

ADDRESSES: Copies of this draft guidance document are available on the 
Internet using the World Wide Web (WWW) at ``http://www.fda.gov/cder/
guidance/index.htm''. Submit written requests for single copies to the 
Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Send one self-addressed adhesive label to assist that office 
in processing your requests. Submit written comments on the draft 
guidance document to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: C. Russ Rutledge, Center for Drug 
Evaluation and Research (HFD-325), 7520 Standish Pl., Rockville, MD 
20855, 301-594-0098, FAX 301-594-2202.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance document entitled ``Investigating Out of Specification 
(OOS) Test Results for Pharmaceutical Production.'' This draft guidance 
document provides guidance to the pharmaceutical industry on how to 
investigate laboratory test results that fall outside of specification 
limits. This draft guidance document describes how to investigate 
results in the laboratory phase, including responsibilities of the 
analyst and supervisor, and if necessary, expand the investigation 
outside of the laboratory to include production, processes, and raw 
materials as appropriate.
    This draft level 1 guidance document is being issued consistent 
with FDA's good guidance practices (62 FR 8961, February 27, 1997). It 
represents the agency's current thinking on OOS test results. 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 requirement of the applicable statute, 
regulations, or both.
    Interested persons may, at any time, submit written comments on the 
draft guidance document to the Dockets Management Branch (address 
above). Two copies of any comments are to be submitted, except that 
individuals may

[[Page 52277]]

submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. The draft guidance 
document and received comments may be seen in the office above between 
9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 21, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-26084 Filed 9-29-98; 8:45 am]
BILLING CODE 4160-01-F