United States of America. The Food and Drug Administration has announced the availability of a draft guidance document entitled “Investigations Out of Specification (OOS) Test Results for Pharmaceutical Production”, the purpose of which is to provide guidance to the pharmaceutical industry on what to do when analytical test results fall outside of specifications (OOS) during pharmaceutical production, including how to investigate laboratory test results that fall outside of specification limits, and if necessary expanding the investigation outside the laboratory to include production processes and raw materials as appropriate.

Copies of the draft guidance documents are available from the Drug Information Branch, (HFM-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville MD 20857, USA (with one self- addressed adhesive label) or from the Internet at: http://www.fda.gov/cder/guidance/index.htm.

Reference: Federal Register 63(189): 52276-77 (1998).