Abstract

The basic purpose of quality assurance in Pharmaceutical manufacturing and supply system is to have a full proof mechanism and exhibitions that every medicine receives by a patient must be safe, effective and pure of acceptable quality. To accommodate all these conditions and parameters, the candidate medicine as well as even established medicine must undergo a series of weathering to make it real perfect and fit for use. To have such medicine, there are established quality standards and set of procedure supported by analytical and instrumental techniques, using variety of physiochemical markers. Pharmaceutical quality is affected by material in use, manufacturing process, packaging and storage conditions and also on some other eco-factors leading to expiration date, decomposition and so on. To have an error free medicine, testing for its standardization require involvement of series of steps using precision instrument under control conditions, utilizing the principle of “Section and discord” such testing conditions require heavy investment, many a times, it is difficult to afford by the Pharma companies also. To cope with such situation, almost all the World Government facilitates testing activities by establishing specialized testing Centre. These Centres provide support to quality standardization, by paying certain amount. However, developing sophisticated analytical testing mechanism to evaluate and also to monitor the quality attributes of drug under examination for purity and structure, require a big list of equipment and highly skill expertise, which in general beyond the internal capacity of a Pharma company and require special attention of World governments; may be in form of establishing such facilities in government sector or outsourcing or maybe through public private partnership (PPP). Whatever procedure/initiatives may be, but it should be given urgent attention by all the country governments involved in Pharma manufacturing sector.