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


Online ISSN : 2347 - 3215
Issues : 12 per year
Publisher : Excellent Publishers
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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.
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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