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[TEMPLATE] 2.3.S Quality Overall Summary 

This 2.3.S Quality Overall Summary - Drug Substance template contains the following sections (in a single document):

-2.3.S.1 General Information
-2.3.S.2 Manufacture
-2.3.S.3 Characterization
-2.3.S.4 Control of Drug Substance
-2.3.S.5 Reference Standards or Materials
-2.3.S.6 Container Closure System
-2.3.S.7 Stability

This 2.3.S Quality Overall Summary - Drug Substance template can be used to further develop the Module 3 Section 3.2.S Drug Substance Section. Please note that the Module 3 Section 3.2.S Drug Substance Section should contain the following sections (in 7 separate documents):

-3.2.S.1 General Information
-3.2.S.2 Manufacture
-3.2.S.3 Characterization
-3.2.S.4 Control of Drug Substance
-3.2.S.5 Reference Standards or Materials
-3.2.S.6 Container Closure System
-3.2.S.7 Stability

*Chemistry, Manufacturing, and Controls

[TEMPLATE] 2.3.S Quality Overall Summary - Drug Substance