Pharmacy Study Material

Free pharmacy material The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMPs). Quality must be built into the design of a facility to ensure that drugs are manufactured under conditions and practices required by the GMP regulations. This concept is broadly embraced across the globe and promulgated by drug regulatory agencies, such as FDA in the United States, the European Medicines Agency in the European Union, and the World Health Organization, whose drug regulations are often used by developing countries and individual countries (e.g., China, India, and Brazil). This principle is further enhanced by the practice of being current. FDA explains the idea of “current” as follows: …the “c” in cGMP stands for “current,” requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been “top-of-the-line” to prevent contamination, mi...