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[RegAffairs]Query on Microbiological Testing of Non-Sterile Drugproducts; Oral Solid Dosage Forms
Good Day Everyone. I'd like to know what test items are required in the Microbiological Testing of Non-Sterile Drug Products; particularly Oral Solid Dosage Forms; in US/EU regulatory CTD submission? In ASEAN CTD submission? From USP 61-62 and 1111 reference; what particular test items are most likely required to be tested ... Thanks. Best regards, Jesus Chinese Pharmaceuticals |
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