CAPA – A Route cause Analysis in Manufacturing Quality System

Authors

  • KIRAN KUMAR B JSS UNIVERSITYJSS COLLEGE OF PHARMACY SS NAGARA,MYSURU-570015,INDIA
  • PRAMOD KUMAR TM

Abstract

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

Author Biography

KIRAN KUMAR B, JSS UNIVERSITYJSS COLLEGE OF PHARMACY SS NAGARA,MYSURU-570015,INDIA

PHARMACUETICAL QUALITY ASSURANCE

References

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Published

2016-04-01

How to Cite

KIRAN KUMAR B, & PRAMOD KUMAR TM. (2016). CAPA – A Route cause Analysis in Manufacturing Quality System. Innovare Journal of Sciences, 4(2), 1-4. Retrieved from https://innovareacademics.in/journals/index.php/ijs/article/view/5522

Issue

Section

Review Article(s)