ABSTRACT

INTRODUCTION The pharmaceutical industry is one of the most regulated consumer industries today. Concerned with the safety of its citizens, governments across the world have set up regulations that govern the manufacturing and distribution of finished pharmaceuticals for human consumption. Like the industry, the regulations are also evolving to meet current business needs and emerging technological developments. Current Good Manufacturing Practices (cGMPs) that were initially well established within the pharmaceutical industry in the United States are now widely used across the globe. Globalization of the pharmaceutical industry has taken place rapidly in recent times, fueled by mergers and acquisitions within the industry and also by economic, political, and regulatory drivers. Regulatory harmonization initiatives at the global and regional levels are making steady progress. In recent years, regulatory agencies in the United States and European Union have encouraged use of new technologies for manufacturing. We are seeing the start of a paradigm shift in how pharmaceutical processes are controlled and how product quality is managed.