Evolution of quality assurance in pharmaceutical industry
1 Sarojini Naidu Vanitha Pharmacy Mahavidyalaya, Tarnaka, Hyderabad, India.
2 Student-Sarojini Naidu Vanitha Pharmacy Mahavidyalaya, Tarnaka, Hyderabad, India.
Review
World Journal of Biology Pharmacy and Health Sciences, 2024, 20(02), 656–661.
Article DOI: 10.30574/wjbphs.2024.20.2.0937
Publication history:
Received on 14 October 2024; revised on 22 November 2024; accepted on 24 November 2024
Abstract:
It is brief review of History of Quality control, Timeline of evolution of quality assurance in pharmacy field, GMP guidelines and current trends. Quality assurance is a term used in systematic process of determining whether a product or service meets specified requirements. Quality assurance also involves establishing and maintaining quality management systems to continually improve processes and prevent defects or deviations. Overall, a Quality assurance plays a critical role in safeguarding public health and maintaining the integrity. The main functions are to provide consumer satisfaction. This article reviews the evolution of quality assurance practices within the pharmaceutical sector, tracing the historical development of quality control measures and examining the pivotal shift towards TQM methodologies. Quality management of pharmaceutical products was started with production premises based on the principle of Good Manufacturing Practices (GMP) and Food and Drug Administration (FDA) regulating bodies. And this aspect includes the quality, efficacy and safety of pharmaceuticals, including the sources like (impurities- residual solvents and various inorganic and organic impurities in pharmaceuticals.).And these Quality controls has policy to control many critical points starting from raw materials, in - process check, equipment, production, packaging material, packing of finished goods till dispatch. Key aspects such as regulatory compliance, technological advancements, and cultural shifts within organizations are analyzed to understand the driving forces behind this evolution. Insights from case studies and industry trends provide valuable perspectives on the current landscape of quality assurance in the pharmaceutical industry, offering practical recommendations for optimizing quality processes and ensuring product integrity and patient safety.
Keywords:
Quality control; Quality assurance; Total quality management; Good manufacturing practices; Food and drug administration
Full text article in PDF:
Copyright information:
Copyright © 2024 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0