Statistics in Pharmaceutical Development and Manufacturing

Journal of Quality Technology vol. 41 issue 2 - April 2009

Abstract:[This abstract is based on the authors' abstract.] An overview is given of the use of statistical thinking and methods in the research and development and manufacturing functions in the pharmaceutical industry. Four case studies illustrate how these issues work in real life settings. A synopsis of these issues concludes that the technical nature of pharmaceutical development and manufacturing offers opportunities for the effective use of statistical methods leading to both process-development understanding and product-quality improvement.

Keywords: Pharmaceutical industry; Statistical methods; Design quality; Research and development (R&D); Statistical quality control (SQC); Product development; Food and Drug Administration (FDA); Case study