Good manufacturing practice tablet manufacture

Two similar dosage forms, eg, tablets, that contain the same amount of the same dmg entity and meet USP/NF and current good manufacturing practices (FDA) are referred to as pharmaceutical equivalents (PE). When, upon adiriinistration, such tablets achieve similar profiles of AUC, and... 

The aim of this chapter is to give an overview of the different techniques used for production and research and further to show the possibilities, that instrumentation of tablet production systems gives in order to analyze the tableting process. The knowledge derived can be used for formulation development as well as to facilitate tablet production and scale-up. Applied techniques which are necessary for production in a good manufacturing practice (GMP) environment will also be discussed. 

Nearly 300 deaths and injuries result from distribution of sulfathiazole tablets tainted with the sedative phenobar-bital. The incident prompts FDA to revise manufacturing and quality controls drastically,the beginning of what would later be called good manufacturing practices (GMPs). 

Only synthetically prepared Ti02 can be used as a color additive. It is permitted in foods to 1 % and is used to color such products as confectionary panned goods, cheeses, and icings. It is also widely used in tableted drug products and in numerous cosmetics such as lipsticks, nail enamels, face powder, eye makeup, and rouges, in amounts consistent with good manufacturing practice (42). 

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