ABSTRACT

The pharmaceutical industry is one of the most regulated consumer industries today. Concernedwith the safety of its citizens, governments across theworld 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 future technological challenges. With the widespread use of the Internet, consumershavebecomebetter informedaboutdrugs, therapies, andhealth risks. Current Good Manufacturing Practices (cGMPs) that were initially well establishedwithin the pharmaceutical industry inUSA are nowwidely 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 factors. Harmonization initiatives seeking to develop common regulatory standards have become increasingly relevant and necessary.