Recently the FDA revised their guidance for procedures for reviewing out-of-specification, or OOS, results in pharmaceutical laboratories. Investigating OOS Test Results was last revised in 2006. While this update contains minor editorial changes and terminology updates, it important to stay current with these FDA revisions. According to GMP Trends® Annual Reports, over the last 5 years the observations pertaining to laboratory investigations, including OOS investigations (21 CFR 211.192) have been in the top 10 observations cited by the FDA each year.
Download the Investigating OOS Test Results for Pharmaceutical Production and stay in compliance with GMP Trends.
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