ABSTRACT

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.

chapter |2 pages

Introduction

part I|31 pages

I Evolution of Process Design and Management

chapter 1|14 pages

1 Why Process Management is Important

chapter 2|15 pages

2 Artisan Heritage

part II|76 pages

II Five Process Elements

chapter 3|15 pages

3 Man: The Mind of the Process

chapter 4|14 pages

4 Machine: The Voice of the Process

chapter 6|13 pages

6 Materials: The Life-Blood of the Process

chapter 7|14 pages

7 Environment

part III|141 pages

III Effective Pharmaceutical Process Design and Management

chapter 8|15 pages

8 Changing the Way We Think

chapter 11|14 pages

11 Process-Driven Quality Systems

chapter 13|19 pages

13 Problem-Solving Tools and Techniques

chapter 14|17 pages

14 Reducing Risk: The New Paradigm

chapter 15|11 pages

15 Customers

chapter 16|15 pages

16 Process Integrated Accounting