Reports and guidance documents; availability, etc.: Pharmaceutical production; investigating out of specification test results; industry guidance,

[Federal Register: September 30, 1998 (Volume 63, Number 189)]

[Notices]

[Page 52276-52277]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr30se98-101]

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Draft Guidance for Industry on Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production; Availability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.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production.'' The purpose of this draft guidance document is to provide guidance to the pharmaceutical industry on what to do when analytical test results fall outside of specifications (OOS) during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DATES: Written comments on the draft guidance document may be submitted by November 30, 1998.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ADDRESSES: Copies of this draft guidance document are available on the Internet using the World Wide Web (WWW) at ``http://www.fda.gov/cder/ guidance/index.htm''.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 Submit written comments on the draft guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a draft guidance document entitled ``Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production.'' This draft guidance document provides guidance to the pharmaceutical industry on how to investigate laboratory test results that fall outside of specification limits. This draft guidance document describes how to investigate results in the laboratory phase, including responsibilities of the analyst and supervisor, and if necessary, expand the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. 98-26084Filed9-29-98; 8:45 am]

BILLING CODE 4160-01-F