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CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES …
database.ich.org9 describes scientific approaches, and presents regulatory considerations specific to CM of drug 10 substances and drug products. 1.2. Scope11 12 This guideline applies to CM of drug substances and drug products for chemical entities and 13 therapeutic proteins. It is applicable to CM for new products (e.g., new drugs, generic drugs,
1086 IMPURITIES IN DRUG SUBSTANCES AND DRUG …
www.uspnf.comSubstances and Drug Products 476 , which addresses organic impurities testing for articles with monographs in relevant USP compendia. This chapter has been updated to align it with current scientific and regulatory standards and to help ensure the appropriate control of organic impurities in drug substances and drug products.