QUALITY CONTROL AND ASSURANCE IN THE PHARMACEUTICAL INDUSTRY: A REGULATORY FRAMEWORK
Abstract
The pharmaceutical industry’s integrity relies profoundly on stringent quality control and assurance measures to ensure the safety and efficacy of medicinal products. This research explores the regulatory framework governing these practices, shedding light on the dynamic landscape shaped by entities such as the FDA and EMA. The paper dissects the components of quality control, emphasizing analytical techniques, and delves into the pivotal role of quality assurance, encompassing Good Manufacturing Practices and robust management systems. Examining challenges and compliance issues, the study draws attention to the consequences of non-compliance and explores technological advancements shaping the future of QC/QA, including automation and data analytics. Through insightful case studies, the paper provides a nuanced understanding of successful implementations and illuminates lessons learned from compliance issues. As the industry evolves, the research anticipates changes in the regulatory landscape and suggests recommendations to enhance QC/QA practices. From the integration of advanced technologies to fostering a culture of compliance, the paper outlines a roadmap for the future. In conclusion, it underscores the paramount importance of continuous improvement in QC/QA processes for the pharmaceutical industry’s sustained success and public trust.
Keywords
Pharmaceutical Industry, Regulatory Framework, Quality Control, Technological Advancements