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Medical Device 사례연구
USP 1663
BRIFING
PURPOSE
KEY TERMS
SCOPE
BACKGROUND
GENERATING THE EXTRACT
EXTRACTING MEDIUM
EXTRACTION TIME & TEMP
CHARACTERIZING THE EXTRACT
SUMMARY
Example Extractables Profiles—Materials Chara
USP 1664
PURPOSE
KEY TERMS
BACKGROUND
CONCEPTS
SAFETY THRESHOLDS
LEACHABLES STUDY DESIGN
LEACHABLES CHARACTERIZATION
SAMPLE PREPARATION
VALIDATION
LEACHABLES–EXTRACTABLES CORRELATION
SIMULATION STUDYS
INORANIC LEACHABLES
USP 1664.1
INTRODUCTION
KEY TERMS
LEACHABLES ASSESSMENT
DOSAGE FORM TYPES
CONSIDERATIONS
ICH Q3E
Concept
Practices and Challenges
Risk Assessment
BPOG RA section
USP1665 RA section
PQRI
PQRI Guidance
PART III Best Practices for E&L Asseessment i
PART III-II Characterization
한국식약처고시
용기적합성평가(MFDS)
가이드라인
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USP 665
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Sterile Filter E&L - EU GMP Annex1
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Genotoxic Impurity
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TUBING SELECTION GUIDE
ValPlus™ Tubing Validation Certification
C-Flex® TPE
Sani-Tech® STHT-65 and STHT-C
Sani-Tech® Ultra-65 and Ultra-C
Sani-Tech® SPT-60L Pump Tubing
Sani-Tech® Sani-Link®
Sani-Tech® STHT®-WR
PharMed® BPT
SANIseal
Single-Use Assemblies
Bioprocess Bags
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Final Fill Custom Assemblies
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Sterile Filter E&L - EU GMP Annex1
Medical Device
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M4 : The Common Technical Document (CTD)
Genotoxic Impurity
Impurity
Protein Characterization
Particulate Matter
Contamination
Container Closure Integrity
Cleanning Validation
Nitrosamine
PFAS
Data integrity
Sanger Sequencing Service
Other Service
SAINT-GOBAIN
TUBING SELECTION GUIDE
ValPlus™ Tubing Validation Certification
C-Flex® TPE
Sani-Tech® STHT-65 and STHT-C
Sani-Tech® Ultra-65 and Ultra-C
Sani-Tech® SPT-60L Pump Tubing
Sani-Tech® Sani-Link®
Sani-Tech® STHT®-WR
PharMed® BPT
SANIseal
Single-Use Assemblies
Bioprocess Bags
Bio-Simplex®
Final Fill Custom Assemblies
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