[Federal Register Volume 71, Number 197 (Thursday, October 12, 2006)]
[Notices]
[Pages 60158-60159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16838]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-0777] (formerly Docket No. 98D-0777)


Guidance for Industry on Investigating Out-of-Specification Test 
Results for Pharmaceutical Production; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Investigating Out-
of-Specification (OOS) Test Results for Pharmaceutical Production.'' 
This guidance provides information for the pharmaceutical industry on 
how to evaluate laboratory test results that fall outside of 
specification limits. The guidance is intended to provide clear and 
consistent communication of

[[Page 60159]]

regulatory expectations and to promote voluntary compliance with 
current FDA requirements.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), 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 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.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Paul W. Haynie, Center for Drug 
Evaluation and Research (HFD-327), Food and Drug Administration, 11919 
Rockville Pike, Rockville, MD 20852, 301-827-9020.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Investigating Out-of-Specification (OOS) Test Results for 
Pharmaceutical Production.'' This guidance document provides guidance 
to the pharmaceutical industry on investigation of laboratory results 
that fall outside of specification limits. The guidance addresses 
investigations of OOS results in the laboratory phase, including 
responsibilities of the analyst and supervisor, and when indicated, the 
expansion of an investigation outside of the laboratory to include 
production processes, and raw materials as appropriate. This guidance 
is intended to apply to traditional methods of drug product testing and 
release, based on testing of discrete samples of in-process materials 
and finished products. The guidance is not intended to address process 
analytical technology, as routine in-process use of these methods might 
include other considerations. The agency, in accordance with its August 
2002 ``Pharmaceutical CGMPs for the 21st Century'' initiative, 
encourages modern approaches to manufacturing, monitoring, and control 
to enhance process predictability and efficiency. The use of continuous 
on-line testing technologies will be addressed in other agency 
guidance.
    In the Federal Register of September 30, 1998 (63 FR 52276), FDA 
announced the availability of a draft guidance of the same title and 
gave interested persons an opportunity to submit comments by November 
30, 1998. The agency received public comments from a broad spectrum of 
the pharmaceutical industry. In response to comments received on the 
draft guidance, the agency made the following changes: (1) Revised the 
scope and background sections to clarify the applicability of the 
document, (2) reorganized the sections on investigating OOS results, 
averaging, and concluding the investigation, and (3) clarified or added 
more specific guidance on certain issues.
    This 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 investigating OOS test results for 
pharmaceutical production. 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 or electronic comments regarding this document. 
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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: October 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-16838 Filed 10-11-06; 8:45 am]
BILLING CODE 4160-01-S