The Application of Statistical Process Control Spc in the Pharmaceutical and Biotechnology Industries

Regulatory authorities have introduced initiatives that encourage companies to investigate and get an understanding of their processes to improve and control. Innovative new technology now allows the measurement and collection of data throughout many manufacturing processes previously unavailable. This book is a starting point for anyone interested or has been tasked to introduce these new pharma initiatives. It is a practical guide on how to apply statistical process control or SPC within the pharmaceutical industry. The book considers the various areas where SPC thinking can be applied and demonstrates the benefits that can be achieved by its use. It encourages all those involved in the industry - whether it be production, quality or the regulatory bodies - to start assessing data in a different way. Although the word 'statistical' appears in the title this is not a book on statistics; however, it does deliver a way of viewing data that is both simple and easy to understand and relates to our understanding of the world in which we work.