FDA Outlines Upcoming Regulatory Changes And Urges Industry To Be Proactive And Transparent
While reviewing upcoming changes heading industry’s way through regulatory legislations, such as the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Drug Supply Chain Security Act (DSCSA), during her keynote session at Pack Expo 2014, Ricki Chase, director of investigations for the FDA’s Chicago office, urged the audience to not just focus on product integrity, but also personal and corporate integrity.
WHITE PAPERS & CASE STUDIES
The Hidden Challenges of Pharmaceutical Serialization
In the almost 40 years since counterfeiting of pharmaceutical products was recognised as a problem by the World Health Organization (WHO), the industry has waged a constant battle against increasingly sophisticated and organised counterfeiters, with drug packaging serving as one of its foremost defences.
Private Branding: How On-Demand Color Labeling Can Add Value To The Growing Generics Market
The generics market has taken off in recent years due to numerous patent expirations for brand-name companies. In light of this, pharmaceutical manufacturers, insurance companies and consumers, in search of significant cost savings, have turned towards the generics industry.
Selecting Robots For Use In Pharmaceutical Manufacturing
Robots can carry out pharmaceutical manufacturing tasks faster, more consistently and more cost-effectively than manual labor.
Highlights On “Equivalent Time” F0 Sterilization
It has been experimentally shown that the reaction of thermal degradation of micro-organisms obeys the laws of a first order chemical reaction (i.e. like a chemical decomposition reaction) in which the reaction rate is proportional, in each moment, only to the amount of product still to be degraded (or decomposed).
How To Calculate The Total Cost Of In-Line Metal Detection Equipment
Considering TCO helps to better understand the costs over and above the purchase price and also – when suppliers have differing offers – to compare them and ultimately to substantiate the investment decision.
Clinical Trial Logistics In Africa: Ensuring Quality, Compliance And Control
Today’s Africa has increasingly become a source of fascination for pharmaceutical researchers drawn to the study and control of both communicable diseases such as malaria, tuberculosis and HIV/AIDS as well as diseases of the developed world like cancer, diabetes, hypertension and chronic respiratory disease. By World Courier