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

Perez jose Rodriguez, CAPA for the FDA regulated industry, ASQ quality press

milwaukee, Wisconsin, (2005) 1-25.

Agile, Almaden Boulevard San Jose, (2002) 1-8.

EMEA, ICH Q 10: Pharmaceutical Quality System, European Medicines Agency,

Westferry Circus, Canary Wharf, London, UK, June (2008) 4-20.

Metric Stream GRC and quality management solutions, Corrective and Preventive

Actions: the cornerstone of effective quality and compliance management in healthcare,

white paper, Bayshore Road Palo Alto, (2010) 1-9.

Bozzone Scott, Process validation of solid oral dosage form, general principals, cork

Ireland, June (2001) 8-34.

Fran Akelewicz, Becton Dickenson, Points to consider when preparing for an FDA

inspection under the QSIT, corrective and preventive actions subsystem, Suite Washington,

June (2001) 4-24.

GHTF, Global Harmonization Task Force, Guidance on Quality Systems for The Design

And Manufacture of Medical Devices, June (1999) 33-36.

Robert J. Latino, Root Cause Analysis: improving performance for bottom-line results,

nd edition, CRC press, Boca Raton London, Washington, D.C., (2002) 1-7.

Published

01-04-2016

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)