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Search results with tag "Fda approaches to process validation"
EMA and FDA Approaches to Process Validation
40rik02ft2xye26xv2i0y0yc-wpengine.netdna-ssl.com“A company can choose to follow different approaches in developing a drug substance. For the purpose of this guideline, the terms “traditional” and “enhanced” are used to differentiate two possible approaches.” Traditional approach: Set points …