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Introduction to CMC Regulatory Affairs - Mamidipudi
Nov 10, 2016 · • Steps of m anufacturing, • Manufacturing flowcharts, • Process parameters Critical Steps in the proc ess are discussed in P.3.4 • Process design , • Process parameters Validation of the manuf acturing process and supporting dat a is provided in section P.3.5 • DP container closure in P.7: Dimensions Materials used
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