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: 2268


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


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


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


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


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


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


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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 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, on 28.03.2015.


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