In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.
This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.
The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.