ISSN2320-2882
Impact Factor9.17
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Paper Title
Role of Quality Assurance in Regulatory Inspections and Audits: A Review
Authors
Ankita Vital Raskar , Mr. D.D. Kodalkar
Keywords
Quality Assurance (QA); Regulatory Inspections; Regulatory Audits; Good Manufacturing Practices (GMP); Pharmaceutical Manufacturing; Data Integrity; Compliance Management; Corrective and Preventive Action (CAPA); Quality Management System (QMS); USFDA; European Medicines Agency (EMA); World Health Organization (WHO); Risk Management; Inspection Readiness; Patient Safety; Documentation Control; Quality Culture.
Abstract
Quality Assurance (QA) plays a critical role in ensuring that pharmaceutical manufacturing operations comply with national and international regulatory requirements. Regulatory inspections and audits conducted by authorities such as the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), and World Health Organization (WHO) are essential mechanisms to verify adherence to Good Manufacturing Practices (GMP), data integrity principles, and product quality standards. QA functions as the central coordinating body that ensures inspection readiness, compliance documentation, risk management, and corrective actions. This review discusses the objectives and types of regulatory inspections, the responsibilities of QA before, during, and after inspections, and the impact of strong QA systems on regulatory compliance, patient safety, and organizational quality culture. Emphasis is placed on inspection preparedness, data governance, CAPA management, and continuous improvement strategies that strengthen pharmaceutical quality systems.
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IJCRT — journal style
"Role of Quality Assurance in Regulatory Inspections and Audits: A Review", IJCRT - International Journal of Creative Research Thoughts (www.ijcrt.org), ISSN:2320-2882, Vol.14, Issue 2, page no.e32-e34, February 2026, Available :https://ijcrt.org/papers/IJCRT2602470.pdf
APA — 7th edition
Raskar, A. V., & Kodalkar, D. D. (2026). Role of Quality Assurance in Regulatory Inspections and Audits: A Review. International Journal of Creative Research Thoughts, 14(2), e32-e34. https://ijcrt.org/viewpaperforall.php?paper=IJCRT2602470
MLA — 9th edition
Raskar, Ankita Vital, and D.D. Kodalkar. "Role of Quality Assurance in Regulatory Inspections and Audits: A Review." International Journal of Creative Research Thoughts, vol. 14, no. 2, 2026, pp. e32-e34, https://ijcrt.org/viewpaperforall.php?paper=IJCRT2602470.
Chicago — 17th, bibliography
Raskar, Ankita Vital, and D.D. Kodalkar. "Role of Quality Assurance in Regulatory Inspections and Audits: A Review." International Journal of Creative Research Thoughts 14, no. 2 (2026): e32-e34. https://ijcrt.org/viewpaperforall.php?paper=IJCRT2602470.
Harvard — author–date
Raskar, A.V. and Kodalkar, D.D. (2026) 'Role of Quality Assurance in Regulatory Inspections and Audits: A Review', International Journal of Creative Research Thoughts, 14(2), pp. e32-e34. Available at: https://ijcrt.org/viewpaperforall.php?paper=IJCRT2602470
IEEE — numbered reference
A. V. Raskar and D. D. Kodalkar, "Role of Quality Assurance in Regulatory Inspections and Audits: A Review," IJCRT, vol. 14, no. 2, pp. e32-e34, Feb. 2026.
Vancouver — biomedical
Raskar AV, Kodalkar DD. Role of Quality Assurance in Regulatory Inspections and Audits: A Review. IJCRT. 2026 Feb;14(2):e32-e34.
AMA — 11th edition
Raskar AV, Kodalkar DD. Role of Quality Assurance in Regulatory Inspections and Audits: A Review. IJCRT. 2026;14(2):e32-e34. Accessed at https://ijcrt.org/viewpaperforall.php?paper=IJCRT2602470
BibTeX — Zotero, Mendeley, LaTeX
@article{IJCRT2602470,
author = {Ankita Vital Raskar and D.D. Kodalkar},
title = {Role of Quality Assurance in Regulatory Inspections and Audits: A Review},
journal = {International Journal of Creative Research Thoughts},
volume = {14},
number = {2},
pages = {e32-e34},
year = {2026},
month = {February},
issn = {2320-2882},
url = {https://ijcrt.org/viewpaperforall.php?paper=IJCRT2602470}
}
RIS — EndNote, RefWorks
TY - JOUR
AU - Raskar, Ankita Vital
AU - Kodalkar, D.D.
TI - Role of Quality Assurance in Regulatory Inspections and Audits: A Review
T2 - International Journal of Creative Research Thoughts
JA - IJCRT
VL - 14
IS - 2
PY - 2026
SN - 2320-2882
UR - https://ijcrt.org/viewpaperforall.php?paper=IJCRT2602470
SP - e32-e34
ER -
Issue
Volume 14 Issue 2,
February-2026
Pages : e32-e34
Article Information
- Published In
- International Journal of Creative Research Thoughts — Volume 14, Issue 2, February 2026
- Pages
- e32-e34
- Published
- February 2026
- Registration ID
- IJCRT_301759
- Published Paper ID
- IJCRT2602470
- Research Area
- Pharmacy All
- Author Type
- Indian Author
- Location
- KOREGAON, MAHARASHTRA, India
- Peer Review
- Request Peer Review Report
- Licence
- CC BY 4.0 · Open Access
- ISSN & Impact Factor
- 2320-2882 · IF 9.17
- Downloads
- 151
- Permanent Link
- https://ijcrt.org/viewpaperforall.php?paper=IJCRT2602470
- Published Paper PDF
- https://ijcrt.org/papers/IJCRT2602470.pdf
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The authors would like to thank the reviewers and the editorial board of International Journal of Creative Research Thoughts for their careful reading and constructive comments, and all colleagues who supported the preparation of this manuscript.
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