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Main
Extractables and Leachables study
E&L Study
Seminar
WEBINAR
2019
2020
2021
2022
2023
E&L case study
FDA 사례연구
MFDS 사레연구
Medical Device 사례연구
USP 1663
BRIFING
PURPOSE
KEY TERMS
SCOPE
BACKGROUND
GENERATING THE EXTRACT
EXTRACTING MEDIUM
TIME & TEMP
CHARACTERIZING
SUMMARY
USP 1664
PURPOSE
KEY TERMS
BACKGROUND
CONCEPTS
SAFETY THRESHOLDS
LEACHABLES STUDY DESIGN
LEACHABLES CHARACTERIZATION
VALIDATION
SIMULATION STUDYS
INORANIC LEACHABLES
USP 1664.1
INTRODUCTION
KEY TERMS
LEACHABLES ASSESSMENT
DOSAGE FORM TYPES
CONSIDERATIONS
ICH Q3E
Concept
한국식약처고시
제2022-80호(22년11월)
용기적합성평가(MFDS)
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Cleanning Validation
Nitrosamine
Data integrity
Other Service
SAINT-GOBAIN
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Silicone Tubing
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Texcell
Becton Dickinson
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PARIS
About Us
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Quality by Design Inc.
Main
Extractables and Leachables study
E&L Study
Seminar
WEBINAR
2019
2020
2021
2022
2023
E&L case study
FDA 사례연구
MFDS 사레연구
Medical Device 사례연구
USP 1663
BRIFING
PURPOSE
KEY TERMS
SCOPE
BACKGROUND
GENERATING THE EXTRACT
EXTRACTING MEDIUM
TIME & TEMP
CHARACTERIZING
SUMMARY
USP 1664
PURPOSE
KEY TERMS
BACKGROUND
CONCEPTS
SAFETY THRESHOLDS
LEACHABLES STUDY DESIGN
LEACHABLES CHARACTERIZATION
VALIDATION
SIMULATION STUDYS
INORANIC LEACHABLES
USP 1664.1
INTRODUCTION
KEY TERMS
LEACHABLES ASSESSMENT
DOSAGE FORM TYPES
CONSIDERATIONS
ICH Q3E
Concept
한국식약처고시
제2022-80호(22년11월)
용기적합성평가(MFDS)
가이드라인
Medical Device
Contract Service
Impurity
SERVICES
ICH Q3A
ICH Q3B
ICH Q3C
ICH Q3D
ICH M7
Protein Characterization
SERVICE
ICH Q6B
mAb Service
Particle
Cleanning Validation
Nitrosamine
Data integrity
Other Service
SAINT-GOBAIN
C-Flex
Silicone Tubing
자료실
용기적합성
Saint Gobain
Texcell
Becton Dickinson
공지사항
Photo
Collection
SWISS
PARIS
About Us
MENU
Main
Extractables and Leachables study
Contract Service
SAINT-GOBAIN
자료실
About Us
Main
Extractables and Leachables study
E&L Study
Seminar
E&L case study
USP 1663
USP 1664
USP 1664.1
ICH Q3E
한국식약처고시
용기적합성평가(MFDS)
Medical Device
Contract Service
Impurity
Protein Characterization
Particle
Cleanning Validation
Nitrosamine
Data integrity
Other Service
SAINT-GOBAIN
C-Flex
Silicone Tubing
자료실
용기적합성
Saint Gobain
Texcell
Becton Dickinson
공지사항
Photo
About Us
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Main
Extractables and Leachables study
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SAINT-GOBAIN
자료실
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용기적합성
Saint Gobain
Texcell
Becton Dickinson
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SWISS
PARIS
Collection
SWISS
PARIS
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