(A) study on contamination control strategy based on critical control points and risk assessment for utility supply system of sterile medicinal products manufacturing facilities

목차 (Table of Contents)

• Table of Contents…………………………………………………….…… i
• List of Figures……………………………………………………….……. iii
• List of Tables…………………………………………………….……..… iv
• List of Abbreviations…………………………………………….….…….. v
• Abstract………………………………………………………...…………. vi
• 1. Introduction……………………………………………………....… 1
• 1.1 Background……………………………………………………...…. 1
• 1.2 Composition of Thesis…………………………………………...… 2
• 2. Materials and Methods………………………………………………. 4
• 2.1 Contamination Control Strategy (CCS)…………………..………... 4
• 2.1.1 Definition of Contamination Control Strategy (CCS)…..……... 4
• 2.1.2 Components of Contamination Control Strategy (CCS)….….... 5
• 2.2 Utility Supply System……………………………………….…..…. 8
• 2.2.1 Definition and Components of Utility System……………..….. 8
• 2.2.2 Considerations for CCS of Utility System……….………...… 10
• 2.3 Risk Assessment Techniques……………………………….……… 11
• 2.3.1 Risk Assessment……………………………………………… 11
• 2.3.2 Simplified Risk Assessment……………………………….…. 11
• 2.3.3 Risk Assessment Techniques…………………………………. 13
• 3. Results………………………………………………………….…. 19
• 3.1 Critical Control Points for Contamination Control Strategy (CCS) for Utility System ……………………………………………………… 19
• 3.2 Actual Application Cases for Utility System based on Risk Assessment…………………………………………………………. 20
• 4. Conclusion and Discussion………………………………………...23
• 5. References……………………………………………………….…24
• Appendix……………………………………………………………….….26
• Abstract in Korean………………………………………….………….….40