Table of Contents
GPhA/OGD Joint Meeting Improving the Quality of Submissions June 26, 2003 Microbiology Review Issues
General Comments
Presentation Overview
DMF/ANDA/NDA References: DMFs
DMF/ANDA/NDA References: ANDAs/NDAs
Bundled/Global Supplements
Organization of ANDAs
Heat Sterilization/Depyrogenation Process Validation
Heat Sterilization/Depyrogenation Process Validation
Heat Sterilization/Depyrogenation Process Validation
Aseptic Processing Buildings and Facilities
Aseptic Processing Sterile Filtration
Aseptic Processing Hold Times
Aseptic Processing Critical Operations
Aseptic Processing Depyrogenation of Containers and Stoppers
EtO Sterilization Process Validation
Radiation Sterilization Process Validation
Sterilization Information in Batch Records
Requalification of Sterilization and Depyrogenation Processes
Media Fills
Media Fills
Media Fills
Media Fills
Media Fills: Acceptance Criteria
Microbiological Environmental Monitoring
Container/Closure Integrity Validation
Antimicrobial Preservative Effectiveness
Endotoxin Test Validation
Sterility Test Validation
OGD Microbiology Team Initiatives
OGD Microbiology Team Initiatives
Consistency Between New Drug and OGD Micro Reviews
CTD Submissions
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