Introduction to CMC Regulatory Affairs - Mamidipudi
Nov 10, 2016 · Critical Steps in the process is discussed in S.2.4 which includes • Process design, • Process parameters Validation of the proc ess and supporting data is provided in S.2.5 The “story” behind how did we come up with the manufacturing process S.2.6 • DS container closure in S.6: Dimensions and materials used
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