ISSN

0974-4150 (Online)
0974-4169 (Print)


Author(s): Chavan Pooja Ajit, Avinash Mahadeo Bhagwat, Atul Prabhakar Chaudhari

Email(s): chavanp978@gmail.com

DOI: 10.52711/0974-4150.2021.00061   

Address: Chavan Pooja Ajit1*, Avinash Mahadeo Bhagwat1, Atul Prabhakar Chaudhari2
1YSPM’s Yashoda Technical Campus, Faculty of Pharmacy (B. Pharm), Satara.
2Lecturet Smt SS Patil Institute of Pharmacy, Chopda, Dist. Jalgaon 425107.
*Corresponding Author

Published In:   Volume - 14,      Issue - 5,     Year - 2021


ABSTRACT:
CAPA is used in the improvements to be made in product, process or quality system to eliminate non-conformities and other undesirable situation. CAPA could be regulatory concept that focuses on systematic investigations to search out the root cause, understanding and correcting discrepancies while attempting to avoid their reoccurrence. Instructions for a way they must be handled within the organization just in case of potential product problems, customer complaints or action to eliminate the cause of a detected nonconformities or incident. Regulatory inspections give more importance for CAPA, for the explanation, it will high light the systems followed within the company additionally because the technical capability of the people concerned. Changes proposed are to be verified and validated to confirm the effectiveness and quality attribution. CAPA is also an integrated part of ISO: 13485 and Good Manufacturing Practice (GMP) for medical products. The FDA defines the purpose of a CAPA procedure as: collecting and analyzing information, identifying and investigating product and quality problems, and taking appropriate and effective corrective and/or preventive action to prevent their recurrence. There is not a regulatory defined framework for the CAPA process only different requirements. The CAPA system investigation document will provide a clear picture of how the standard system works and hence, Regulatory Inspectors give lot of importance to audit this method. Real root cause is to be identified with scientific proof and which further may not be generated. This review provides comprehensive views on steps involved in corrective action and preventive action (CAPA), mechanism of taking CAPA enabling to boost the system of quality management. CAPA is a component of the overall quality management system. As per the FDA documents CAPA accounts for 30-50% of FDA-483 forms issued for noncompliance.


Cite this article:
Chavan Pooja Ajit, Avinash Mahadeo Bhagwat, Atul Prabhakar Chaudhari. CAPA: An important concept of Quality Assurance in Pharmaceutical Industry. Asian Journal of Research in Chemistry. 2021; 14(5):357-2. doi: 10.52711/0974-4150.2021.00061

Cite(Electronic):
Chavan Pooja Ajit, Avinash Mahadeo Bhagwat, Atul Prabhakar Chaudhari. CAPA: An important concept of Quality Assurance in Pharmaceutical Industry. Asian Journal of Research in Chemistry. 2021; 14(5):357-2. doi: 10.52711/0974-4150.2021.00061   Available on: https://ajrconline.org/AbstractView.aspx?PID=2021-14-5-10


REFERENCES:
1.    R.M. Baldwin. Preventive/Corrective Actions (CAPA) Guidelines. Introduction.
2.    Corrective and Preventive Action. Wikipedia. Introduction.
3.    Andy Marker. The Beginner’s Guide to CAPA. Definition. Smart sheet. 2018.
4.    CAPA| Beginner’s Guide to Corrective Action Preventive Action. Difference between Corrective Action and Preventive Action. Softwaretestinghelp.com. 2021.
5.    Corrective and Preventive Actions (CAPA)| FDA. Objective. 2014.
6.    Martin Van Trieste. CAPA within the Pharmaceutical Quality System. CAPA per ICH Q10. Brussels, Belgium. 2011.
7.    Ankur Choudhary. Importance of Corrective and Preventive Action (CAPA). Importance. Pharmaceutical guidelines.
8.    Robert Fenton. 5 Fundamentals of the CAPA Quality Process. Fundamental of CAPA. Qualio. 2020..
9.    Dr. Deepak. What are Different stages of CAPA in Quality Control Operations?. Procedure of CAPA. Lab.Training.com. 2015.
10.    Juhlian Pimping. CAPA Report Templates. CAPA Report. Safety Culture. 2020.

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