African Journal of
Pharmacy and Pharmacology

  • Abbreviation: Afr. J. Pharm. Pharmacol.
  • Language: English
  • ISSN: 1996-0816
  • DOI: 10.5897/AJPP
  • Start Year: 2007
  • Published Articles: 2250

Review

A review on corrective action and preventive action (CAPA)

Abhishek Raj
  • Abhishek Raj
  • Deputy R&D Manager, Quest Pharmaceuticals Pvt. Ltd, Chhata Pipara, Bara, Birgunj, Nepal.
  • Google Scholar


  •  Received: 23 June 2015
  •  Accepted: 19 August 2015
  •  Published: 08 January 2016

References

Code of Federal Regulations CFR (2015). Title 21, Part 820, www.accessdata.fda.gov on 05.05.2015.

 

Corrective Action Preventive Action (2015). Defining alternatives to training as a root cause, www.mnasq.org on 24.03.2015.

 
 

Denise ER (2001). The Corrective Action Handbook, 2nd Edition. 132p

 
 

Difference between Containment, Corrective and Preventive Actions in 8D report,www.8dreport.com on 02.04.2015.

 
 

How to create a corrective and preventive action plan (2015). Guidelines for writing a CAPA, www.feinsteininstitute.org on 05.05.2015.

 
 

ICH (2005). Harmonised tripartite guideline, Quality Risk Management, Q9, version 4, November 2005.

 
 

ISO 9000 (2005). 9000 Quality Management System-Fundamentals and vocabulary. ISO 2005.

 
 

James PR, Terry R (2000). After the Quality Audit: Closing the Loop on the Audit Process.

 
 

Joseph DN (2006). Good Manufacturing Practices for Pharmaceuticals, 6th Edition. 424 pp.

 
 

Ken P (2015), Improving CAPA systems with a closed-loop methodology, assessed online from www.mastercontrol.com on 02.04.2015.

 
 

Kimberly LW (2008). Food and Drug Administration, Division of domestic field investigations, office of regulatory affairs, Corrective and Preventive Action-Background and examples.

 
 

Larry K, Chair GHTF (2010). Quality Management System-Medical Devices-Guidance on corrective action and preventive action and related QMS processes, GHTF/SG3/N18:2010.

 
 

MarliseGyger Ms (2012). ETH, Corrective Actions and Preventive Actions, Quality and GMP, June.

 
 

Michael BW (1997). Total Quality Safety Management and Auditing.

 
 

Nonconformance and Corrective and Preventive Action-Background and exhibits,www.epa.gov on 28.03.2015.

 
 

Tonya W (2013). Corrective and Preventive Actions, A five step approach.