Pharmaceutical Process Design And Management

This excerpt from a textbook on pharmaceutical process design and management discusses the different elements that go into creating a quality product or service, as well as the various steps that need to be taken in order to manage a process effectively. The book also discusses the importance of quality control and quality assurance, as well as the various tools that can be used to improve the quality of a product or service. Finally, the book provides an overview of how to approach process design and management using a science and risk-based approach.

A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.