About the Book:

Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models. 

Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice. 

Contents:

Part A: Most Suitable Environment

1.    Introduction

2.    Technology Transfer and the Climate of Change

3.    Quality Systems Structure and a Maximum Quality Environment

Part B: Setting Process Bounderies

4.    Validation

5.    Good Manufacturing Practices

6.    Process Control via Numerical Means

7.    Product Verification and the Role of Qualified Personnel

8.    In-Process and On-Process QC Testing and Control

Part C: Starting from Scratch

9.     New Products Manufacturing

10.  Questions and Problems