Pharmaceutical Industry Drug Quality Assurance: Strategies for Handling Deviations, Changes and Validations

© 2025 by the Author. Licensee Whioce Publishing, Singapore. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution -Noncommercial 4.0 International License (CC BY-NC 4.0) ( https://creativecommons.org/licenses/by-nc/4.0/ )

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Abstract

Ensuring the quality of drugs is of utmost importance in the pharmaceutical industry. This article explores strategies for handling deviations, changes, and validations, covering aspects such as preventing deviations, change control, process validation, and cleaning validation. It introduces risk identification and mitigation strategies, emphasizes supplier qualifications and supply chain transparency, points out the significance of integrating data-driven indicators with regulatory intelligence, and calls for integrating quality assurance methods to address new challenges.

Keywords

Drug quality

Deviations

Changes

Validation

Quality assurance strategies

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