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 CONSIDERATIONS FOR MULTI-PRODUCT OPERATIONS 3.5 VIRAL CLEARANCE 3.6 STAGE OF PRODUCT DEVELOPMENT 3.7 OPERATIONAL UPSET 3.8 OPERABILITY AND MAINTAINABILITY 3.9 CLEANING AND HOUSEKEEPING CONSIDERATIONS 4 CHAPTER 4: PROCESS AND EQUIPMENT 4.1 EXECUTIVE SUMMARY 4.2 TYPICAL BIOPHARMACEUTICAL PROCESSES 4.3 CRITICAL PROCESS PARAMETERS 4.4 GENERAL CONSIDERATIONS FOR EQUIPMENT DESIGN 4.5 SPECIFIC EQUIPMENT DESIGN CONSIDERATIONS 4.6 SUMMARY 5 PROCESS SUPPORT AND UTILITIES 5.1 EXECUTIVE SUMMARY 5.2 REGULATORY ISSUES 5.3 SYSTEM IMPACT DESCRIPTIONS 5.4 SYSTEM LAYOUT AND ROUTING 5.5 SPECIFIC SERVICE CONSIDERATIONS 6 FACILITY 6.1 EXECUTIVE SUMMARY 6.2 PROCESS CONSIDERATIONS 6.3 OPERATIONAL CONSIDERATIONS 6.4 FACILITY LAYOUT CONSIDERATIONS 6.5 OPERATIONAL SUPPORT 6.6 AREA ENVIRONMENT 6.7 ARCHITECTURE AND FINISHES 6.8 DISCRETIONARY CONSIDERATIONS 7 PROCESS CONTROLS 7.1 EXECUTIVE SUMMARY 7.2 BIOPHARMACEUTICAL AUTOMATION ISSUES 7.3 LEVEL OF AUTOMATION 7.4 BIOPHARMACEUTICAL UN...
