A GUIDE FOR NEW FACILITIES VOLUME 6: BIOPHARMACEUTICALS EXECUTIVE SUMMARY OF DRAFT FOR REVIEW JANUARY 2003 1-1 Copyright: This document is owned by ISPE
No reproduction of the whole or any part of this document is to be made without the written authority of ISPE
1-2 ISPE BASELINE® GUIDE EXECUTIVE SUMMARY BIOPHARMACEUTICALS JANUARY 2003 CONTENTS 1 INTRODUCTION 1
1 BACKGROUND 1
2 SCOPE OF THE GUIDE 1
3 KEY CONCEPTS OF THE GUIDE 1
4 USING THE GUIDE 2 THE REGULATORY BASIS FOR FACILITY REQUIREMENTS 2
1 EXECUTIVE SUMMARY 2
2 SCOPE 2
3 DEFINITIONS 2
4 REGULATORY CONSIDERATIONS 2
5 GENERAL CONCEPTS 2
6 BIBLIOGRAPHY 2
7 SIGNIFICANT REGULATORY DOCUMENTS 3 MANUFACTURING OPERATIONS AND ACTIVITIES 3
1 EXECUTIVE SUMMARY 3
2 OPEN VERSUS CLOSED SYSTEMS 3
3 PYROGEN-CONTROLLED PROCESSING 3
4 CONSIDERATION
