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@article{187368,
        author = {Mr. Kuvarsing J.  Valvi and Mr.  Shubham S. Vaidya},
        title = {Role of Quality Assurance in Ensuring Good Manufacturing Practice (GMP) Compliance},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {6},
        pages = {3926-3933},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=187368},
        abstract = {Good Manufacturing Practices (GMP) form the cornerstone of pharmaceutical quality systems, ensuring that medicinal products are consistently produced, controlled, and released in accordance with predefined quality standards. Within this framework, Quality Assurance (QA) serves as the central, authoritative function responsible for establishing, monitoring, and continuously improving all systems that affect product quality and regulatory compliance. QA ensures that every manufacturing activity ranging from raw material procurement to finished product release is performed according to validated procedures, scientifically justified controls, and globally accepted GMP guidelines. This review article evaluates the comprehensive role of QA in achieving GMP compliance, including oversight of documentation and data integrity, equipment and process validation, deviation and CAPA (Corrective and Preventive Action) management, change control, supplier qualification, risk assessment, and internal auditing. The abstract also highlights the importance of QA in maintaining batch-to-batch consistency, minimizing process variability, preventing contamination, and ensuring full traceability throughout the product lifecycle. Furthermore, modern advancements such as Quality by Design (QbD), digital quality management systems, real-time monitoring, and risk-based quality approaches (as outlined in ICH Q9 and Q10) have strengthened the effectiveness of QA, enabling proactive decision-making and enhanced regulatory readiness. In conclusion, Quality Assurance remains the backbone of GMP compliance by ensuring that every stage of pharmaceutical manufacturing upholds the highest standards of quality, safety, and efficacy ultimately safeguarding patient health and supporting global regulatory expectations.},
        keywords = {QA, GMP, Compliance, CAPA, Validation, Documentation, Audits, Quality System.},
        month = {November},
        }