Investigations. Deviations (All departments)Out-of-Specification (QC Lab)Out-of-Trend (QC Lab)Raw MaterialsComponentsContainers/ClosuresAPIFinished Drug Product. Deviations. Associated with limits vs. specificationsGMP mistakes or errorsReprocessing or ReworkUnapproved changesPerforming
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DEVIATION INVESTIGATIONS A Proper Objective Perspective
FDA USP Conference
December 5, 2008
Deviations Investigations vs. Batch Release (Product Impact Assessments)
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).
CDR Jeffrey T. Yuen, MPH, MBA
President – Principal Consultant
Jeff Yuen and Associates
P.O. Box 6026
Orange, CA 92863-6026
Phone: 714 282-1014
E-Fax: 240 597-8351
Reproduction or Copies
Further reproduction, copies, or use of this presentation without explicit permission from Jeff Yuen and Associates is strictly prohibited.
November 13, 2003