AccScience Publishing / AIH / Volume 3 / Issue 1 / DOI: 10.36922/AIH025160032
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REVIEW ARTICLE

Transforming pharmaceutical quality assurance and validation through artificial intelligence

Vaibhav Adhao1* ,  Jaya Ambhore1* ,  Shreyash Chaudhari1
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1 Department of Quality Assurance, Dr. Rajendra Gode College of Pharmacy, Malkapur, Maharashtra, India
AIH 2026, 3(1), 18–28; https://doi.org/10.36922/AIH025160032
Received: 17 April 2025 | Revised: 29 July 2025 | Accepted: 1 August 2025 | Published online: 13 August 2025
© 2025 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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Abstract

The evolution of artificial intelligence (AI) in the pharmaceutical industry spans from its early applications in automating administrative tasks to its pivotal role in drug discovery, personalized medicine, and safety enhancement. AI contributes significantly to data analysis, real-time process monitoring, defect detection, predictive maintenance, and compliance assurance, thereby enhancing efficiency, accuracy, and regulatory adherence. This review assesses the transformative functions of AI integration in revolutionizing quality assurance and validation across the pharmaceutical industry and highlights the contribution of AI in advancing quality frameworks, core values, and smart manufacturing. Moreover, the role of AI in enhancing validation processes and the critical importance of data and algorithms are discussed. As AI continues to reshape the pharmaceutical industry, it emphasizes the synergy between technological innovation and quality enhancement.

Keywords
Artificial intelligence
Quality assurance
Validation
Pharmaceutical industry
Software development
Predictive maintenance
Compliance
Funding
None.
Conflict of interest
The authors declare they have no competing interests.
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Artificial Intelligence in Health, Electronic ISSN: 3029-2387 Print ISSN: 3041-0894, Published by AccScience Publishing
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