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Labcompliance News, November 1998

Nov 1, 1998

New FDA 'Out of Specification' Draft Document

The FDA has released a new guidance document on how to investigate Out of Specification (OOS) test results for pharmaceutical production. The guidance provides the agency's current thinking on how to evaluate suspect, or out of specification, test results. The guidance applies to laboratory testing during the manufacture of active pharmaceutical ingredients, excipients, and other components and the testing of finished products.