Investigating Out-of-Specification Results and Development CAPA Program for Pharmaceutical Industries: An Overview

[摘要] 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 can help prevent potential problems in the future.

[学科分类] 药理学