Abstract Volume:5 Issue-10 Year-2017 Original Research Articles
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Online ISSN : 2347 - 3215 Issues : 12 per year Publisher : Excellent Publishers Email : editorijcret@gmail.com |
2Department of Pharmaceutical Quality Assurance, Sanjivani College of Pharmaceutical Education and Research, Kopargaon, Maharashtra-423603, India
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.

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): 27-33doi: https://doi.org/10.20546/ijcrar.2017.510.005



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