Guide to Pharmaceutical Product Quality

摘要: Most drug constituents have a particulate nature, the properties of which may be critical for both manufacturing process and final quality. This chapter discusses means to reach maintain optimum quality pharmaceutical products. A scientific basis, as promoted by approach Quality Design (QbD), identification, measurement control attributes products processes, with special attention particle size, shape morphology, provide good opportunities decreasing their development time. In addition, Process Analytical Technology (PAT) framework, promotes application modern analytical instruments chemometric tools monitoring control, offers shorten optimize including changes from batch continuous processes. Thus, stable product result at reduced costs if processes are based on knowledge instrumentation. further summarizes general ICH guidelines Moreover, it aspects some methods techniques size analysis shape, acceptance criteria distributions, well qualification methods, management