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Drugs

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CMC - Microbiology (Chemistry, Manufacturing, and Controls)

 Title and Format  Type  Issue Date
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (PDF - 57 KB) Final 11/1994
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 76 KB) Draft 8/4/2008
    
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