DEVIATION INVESTIGATIONS A Proper Objective Perspective. FDA USP Conference Irvine, CA December 5, 2008. Investigations. Deviations (All departments) Out-of-Specification (QC Lab) Out-of-Trend (QC Lab) Raw Materials Components Containers/Closures API Finished Drug Product. Deviations.
FDA USP Conference
December 5, 2008
Batch release should be considered a separate and distinct QA function and activity!
Product Impact Assessments should be done “collectively” (summation of all deviations) after an appropriate deviation investigation has been completed.
All deviations must then be collectively evaluated at the time of final batch release.
Definitive vs. Potential Root Causes
THERE IS A BIG DIFFERENCE BETWEEN WHAT HAPPENED VS. WHY OR HOW SOMETHING HAPPENED!
General FDA 483 Observation
Corrective actions do not ‘match’ or support definitive or potential root causes.
Preventive actions must focus on ‘system’ evaluations and ‘system’ level continuous improvement.
Quality system improvement is more important to FDA than corrective actions (band-aid fixes necessary to just release a batch).
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November 13, 2003