Pharmaceutical Quality/Microbiology

Below is a sortable listing of Pharmaceutical Quality/Microbiology  guidances.

*Note: The category “CMC – Microbiology (Chemistry, Manufacturing and Controls) is renamed to Pharmaceutical Quality/Microbiology

Pharmaceutical Quality/Microbiology Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (PDF - 57KB) Final Guidance 11/01/94
Pharmaceutical Quality/Microbiology Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB) Final Guidance 02/25/10
Pharmaceutical Quality/Microbiology Format and Content of the Microbiology Section of an Application* (PDF - 546KB) Final Guidance 01/01/90

Page Last Updated: 12/07/2014
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