In the most general terms, an over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctor’s prescription. Self-medication is a common treatment of many routine health problems such as headaches, allergies, and skin conditions. OTC drugs are designed, labeled, and approved by various regulatory agencies around the world for use...
Turning a promising drug candidate into a successful pharmaceutical product involves scaling-up the processes, developed in the research lab, in order that commercial supply can be achieved. The technical hurdles involved in making this transfer can be daunting. Also, it is not uncommon for changes to be made in the manufacturing process and/or chemistry of a drug product following approval and...
Understanding is the foundation of a successful outsourcing relationship. When it comes time to outsource a pharmaceutical project, the drug developer must share the results of their hard work and innovation in the R&D lab or at the production site with the manufacturing contractor. It is vital this manufacturing (and packaging) information is fully understood by the CDMO so the bench top...
GxP is a general term used to describe the quality guidelines and regulations applied in the pharmaceutical industry. GxP is the abbreviation of “Good x Practice”. The “x” in GxP stands for the field the guidelines and regulations applied to. Here are examples of GxPs often seen in the pharmaceutical industry: GMP - Good Manufacturing Practice GLP - Good Laboratory...