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.

Recomonded Articles:

Author(s): Tanveer Hasan, Raza Murad Ghalib, Sayed Hasan Mehdi, P. K. Singh, S. S. R. Baqri

DOI: 10.5958/0974-4150.2017.00132.8         Access: Open Access Read More

Author(s): M Nagarajan, AJM Christina, P Devi, R Meera

DOI:         Access: Open Access Read More

Author(s): Rachana Rani, Sudeep Mishra

DOI:         Access: Open Access Read More

Author(s): G.V. Pavan Kumar, R. Divya, V. Pratyusha, G. Monica

DOI:         Access: Open Access Read More

Author(s): Omprakash Bhargava, Suresh Kumar Sutrakar, Pawan Ghanghoria, Arvind Verma

DOI: 10.5958/0974-4150.2015.00039.5         Access: Open Access Read More

Author(s): K. Mamatha, N. Gandhi, D. Sirisha

DOI:         Access: Open Access Read More

Author(s): K. Venugopal, P. Sivajyothi, P. Ashok Gajapathi Raju, J. Sreeramulu

DOI:         Access: Open Access Read More

Author(s): Ahmed Yahya Issa Rubaye, Ali Abdulrazzaq Abdulwahid, Hassan Thamir Abdulsahib

DOI: 10.5958/0974-4150.2015.00068.1         Access: Open Access Read More

Author(s): Obagboye Fredrick O., Olasehinde Emmanuel F., Oyewumi Mayowa, Tomilawo Busayo A.

DOI: 10.5958/0974-4150.2020.00029.2         Access: Open Access Read More

Author(s): Suresh Kumar Sutrakar, Drutpal Singh Baghel

DOI:         Access: Open Access Read More

Author(s): Y.N.Ch. Ravi Babu, S.V.G.V.A. Prasad, M. Kiran Kumar, A. Suresh Kumar

DOI:         Access: Open Access Read More

Author(s): Mahendrasinh Raj, Lata Raj

DOI:         Access: Open Access Read More

Author(s): Souad Belakehal, Brahim Labed, Louiza Zenkhri, Khedidja Benzahi, Ahmed Tabchouche

DOI: 10.52711/0974-4150.2021.00049         Access: Closed Access Read More

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

DOI: 10.52711/0974-4150.2021.00061         Access: Closed Access Read More

Asian Journal of Research in Chemistry (AJRC) is an international, peer-reviewed journal devoted to pure and applied chemistry..... Read more >>>

RNI: Not Available                     
DOI: 10.5958/0974-4150 

Popular Articles


Recent Articles




Tags