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OOS (Out-of-Specification) Regulations

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Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
This guidance for industry provides the Agency's current thinking on how to evaluate suspect, or out of specification (OOS), test results. For purposes of this document, the term OOS results includes all suspect results that fall outside the specifications or acceptance criteria established in new drug applications, official compendia, or by the manufacturer, FDA

 1998-01-01   PDF PDF file (37 KB) 

Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
PDA comments on the draft guidance for industry, Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production, September 30, 1998.

 1998-01-01   PDF PDF file (56 KB) 

U.S. vs. Barr Laboratories: A Technical Perspective
A ruling dated February 4, 1993, Judge Alfred Wolin of the U.S. District Court for the District of New Jersey handed down a ruling that has already shaped interpretation of the pharmaceutical CGMP regulations by industry and the FDA. This case resulted from numerous FDA inspections of Barr's plants in Northvale, New Jersey and Pomona, New York in mid-1991 and 1992.

 1993-09-13   PDF PDF file (40 KB) 

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