Analysis uncovers the role of quality assurance and regulatory compliance in pharmaceuticals, highlighting patient safety.
The Quality Assurance (QA) and Quality Control (QC) divisions are essential in upholding the quality, safety, and reliability of pharmaceutical products. QA takes a proactive and structured approach by formulating standard operating procedures, conducting regular audits, training staff, and ensuring strict adherence to regulatory guidelines, with focus on the 5Ms—Man, Material, Machinery, Method, and Motivation. Conversely, QC functions as a corrective system, aimed at identifying and resolving defects through systematic inspections, testing, documentation, and regulatory compliance checks at different stages of production. Working in tandem, QA and QC protect patient health, ensure compliance with global standards, improve process efficiency, and enhance market credibility by guaranteeing data accuracy and fostering worldwide confidence in pharmaceutical products.
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Sudev et al. (2025) studied this question.
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