Management Study In Development Of Copy Of Active Pharmaceutical Ingredients

With the development of living standard, the requirement of life quality isimproved gradually, and the demand of drug varieties and quantity is extended aswell. It is hoped that safe, reliable, effective, quality stable and price reasonabledrugs can be available. Reference listed drugs (RLD) are original drugs. However,the reference listed drugs cannot meet the drug demand in our daily life due to thehigh price and limited manufacturer. Generic drugs are drugs generic manufacturedafter the pattern expires with the equivalent structure, effect and therapy method withreference listed drugs. Due to the lower price, the generic drug can lower the cost ofdrug, provide sufficient quantity of drug and bring positive economic benefit to thegeneric manufacture at the same time. So the generic drug development andmanagement has important practical significance.The article adopts the method of project management, to the process of genericdevelopment of API, from market research, feasibility study, laboratory research anddevelopment, pharmaceutical production license, drug registration approval, GMPcertification, until commercial production process were studied. Combining with aninstance of ABC generic development, discussed emphasis of the process ofdeveloping and involves management tools. Aimed at the difficult in the developingprocess of API, regulations, technical, work multifarious, long time, laboratory andproduction disconnect, drug quality consistency evaluation, countermeasure andsuggestions are given.