IJCRAR is now DOI (CrossRef) registered Research Journal. The DOIs are assigned to all published IJCRAR Articles.

INDEXED IN INDEX COPERNICUS - ICI Journals Master List 2016 - IJCRAR--ICV 2016: 81.15 For more details click here

Abstract            Volume:5  Issue-10  Year-2017         Original Research Articles


Online ISSN : 2347 - 3215
Issues : 12 per year
Publisher : Excellent Publishers
Email : editorijcret@gmail.com

Basics of Corrective and Preventive Action: Quality Management Tool
Subrata Sarkar1* and Vipul P. Patel2
1Research Scholar, Bhagwant University, Ajmer, Rajasthan, India
2Department of Pharmaceutical Quality Assurance, Sanjivani College of Pharmaceutical Education and Research, Kopargaon, Maharashtra-423603, India
*Corresponding author
Abstract:

CAPA is a fundamental management tool that should be used in every quality system. This program provides a simple step by step process for completing and documenting corrective or preventive actions. The result will be a complete, well documented investigation and solution that will satisfy regulatory requirements and form the basis for an effective continuous improvement plan for any company. To establish a Corrective and Preventative Actions (CAPA) Program for conducting and documenting internal activities for continual assessment of compliance with clinical trial protocols, established regulations, ICH GCP guidelines, internal standard operating procedures, and policies to actively seek quality process improvements. Globally, this system is established as the Corrective and Preventative Actions (CAPA) Program for the research. This procedure is applicable to the Corrective and Preventative Actions (CAPA) Program and Clinical Operations functional areas. It applies to all clinical research team members involved in the regulatory implementation and coordination of Clinical Investigations. CAPA is a fundamental management tool that should be used in every quality system. This program provides a simple step by step process for completing and documenting corrective or preventive actions. The result will be a complete, well documented investigation and solution that will satisfy regulatory requirements and form the basis for an effective continuous improvement plan for any company.

Keywords: CAPA, ICH, Clinical trials and GCP guidelines.
Download this article as Download

How to cite this article:

Subrata Sarkar and Vipul P. Patel. 2017. Basics of Corrective and Preventive Action: Quality Management Tool.Int.J.Curr.Res.Aca.Rev. 5(10): 27-33
doi: https://doi.org/10.20546/ijcrar.2017.510.005
Copyright: This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike license.