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Fema Design Guidelines

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Preview of EMA/CHMP/BWP/187338/2014: Guideline on Process Validation for the Manufacture of Biotechnology-Derived Active Substances and Dat
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EMA/CHMP/BWP/187338/2014: Guideline on Process Validation for the Manufacture of Biotechnology-Derived Active Substances and Dat (guideline-process-validation-manufacture-biotechnology-derived-active-substances-data-be-provided_en.pdf)

181 KBEuropean Medicines AgencyEN 13 pages
The European Medicines Agency (EMA) issued a guideline on process validation for biotechnology-derived active substances, covering process characterisation and...
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