GOOD PRACTICES IN PHARMACEUTICAL PREMISES AND EQUIPMENT

This book presents a unique perspective. It outlines the techinal requirements for pharmaceutical manufacturing as supported by the underlying science with full consideration of the regulatory environment. Sound science and management skill in this industry in insufficient for compliance to regulations, the universe of regulations must be understood and appropriate measures taken to ensure adherence to those regulation imposed. Mr. Botet has provided the reader with a comprehensive treatise that provides near equal measure of science, common sense, business tools and compliance. The text reviews the regulatory climate, and then provides practical guidance to aid the reader in developing measures to conform with global regulations and guidance documents. The book is profusely illustrated, with numerous photographs, and diagrams aiding in the clarity of presentation. Summary tables outlining requirements are provided allowing for better understanding of varying requirements. The result is a unique contribution to the industry, and one that is certain to be a useful resource to both industry and regulators.