Guide to pharmaceutical product quality

Abstract

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