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Article: Firm cited for averaging OOS outcomes in new drug testing.(Baxter Healthcare Corp., out-of-specification)(Brief Article)
- Article from:
- Validation Times
- Article date:
- February 1, 2002
CopyrightCOPYRIGHT 2002 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Baxter Healthcare showed up on FDA's radar screen after an Aug. 7-17, 2001, audit of the Round Lake, IL, plant disclosed averaging of OOS outcomes for stability tests involved in amended new drug and new drug applications.
In two instances, the OOS outcome was for the color of the unnamed substance and the other two were for molecular weight distribution and chloride content.
The just-released Nov. 2, 2001, letter stated Baxter averaged five outcomes for a theophiline assay for two unnamed drugs each of which failed once. The firm was said to have assayed four other samples and averaged the five results without invalidating the single failed outcome.
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