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Table Of Contents

A. STRATEGY
B. INSPECTION PLANNING
C. PROFILE REPORTING
PART III - INSPECTIONAL
3.1 TYPES OF STERILIZATION
3.2 REPORTING
3.3 INSPECTION APPROACHES
3.4 SYSTEM INSPECTION COVERAGE
3.5 QUALITY SYSTEM
3.6 FACILITIES AND EQUIPMENT SYSTEM
A. FACILITIES
B. EQUIPMENT
3.7 MATERIALS SYSTEM
3.8 PRODUCTION SYSTEM
3.9 PACKAGING AND LABELING SYSTEM
3.10 LABORATORY CONTROL SYSTEM
6.3 CONTACTS
MOIST HEAT STERILIZATION
DRY HEAT STERILIZATION / DEPYROGENATION
ASEPTIC FILLING
ISOLATOR BARRIER TECHNOLOGY
ENVIRONMENTAL MONITORING – Non-viable
ENVIRONMENTAL AND PERSONNEL MONITORING – Microbiology
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ucm125409.pdf

ucm125409.pdf

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Published by: pradeep281001 on Oct 17, 2013
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