A Review on Quality Assurance and Quality Management System in Pharmaceutical Industry
Year: 2024
Type: article
Abstract: Quality assurance (QA) and quality management (QM) are critical pillars in pharmaceutical science and industry, ensuring the safety, efficacy, and reliability of pharmaceutical products. QA focuses on implementing systems and processes to prevent quality issues, emphasizing Good Manufacturing Practices (GMP), documentation, and regulatory compliance. On the other hand, QM provides a comprehensive framework, integrating QA and quality control (QC) with strategies like Quality by Design (QbD), risk management, and continuous improvement. Together, QA and QM uphold global regulatory standards, foster innovation, and enhance product quality, ultimately safeguarding public health and building trust in pharmaceutical products. The pharmaceutical industry relies heavily on robust quality assurance (QA) and quality management (QM) systems to ensure the production of safe, effective, and high-quality medicines. This project explores the principles and implementation of QA and QM, highlighting their roles in compliance with regulatory frameworks such as Good Manufacturing Practices (GMP) and ICH guidelines. QA focuses on preventing errors through well-defined processes, while QM integrates QA and quality control (QC) to establish a culture of continuous improvement and risk management. By analysing real-world applications, this project underscores the importance of QA and QM in enhancing patient safety, regulatory adherence, and operational efficiency within the pharmaceutical sector.
Author: Om Chankhore, Tejas Sharma*, Shivshankar Mhaske
Language: English
Subfield: Strategy and Management
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W6968328720
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