CAPA â€“ A Route cause Analysis in Manufacturing Quality System
A well designed and implemented corrective and preventive action (CAPA) offers a mechanism for obtaining critical quality data in a timely manner to enable quick response to
out-of-specification (OOS), early warning of potential failures and redeployment of resources
to problematic areas. This article presents the key features of CAPA program and provides
the current thinking on how to evaluate out-of-specification test results that can lead to detection and resolution of out-of-specification test results for pharmaceutical production. In
order to solve OOS, every organization must know how to conduct an effective investigation,
identify root causes and implement workable corrective action in a timely manner that canhelp prevent potential problems in the future
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