Is it necessary for the source of anypeptone used (e.g. animal or vegetable origin) in the fermentation process forthe production of active substances to be included in relevant dossiers?
在发酵过程中，生产活性物质所使用的任何蛋白胨(如动物或植物来源)的来源是否必须列入相关档案？
1 回答
Yes.Peptone is considered to be a critical raw material, whose origin (animal orvegetable) and source (supplier name and address) should be specified inany Active Substance Master File (ASMF), Certificate of Suitability (CEP) and whererelevant Marketing Authorisation (MA) dossiers. Consequently, if there is any change to theregistered information, the change should be sought by appropriate variation (CEP or MA) and for transparency and to ensure relevantresponsibilities are adhered to, the change should be immediately communicatedto any finished product manufacturer who uses the material.
是的。蛋白胨被认为是一种关键原料，其来源(动物或植物)和来源(供应商名称和地址)应在任何活性物质主文件(ASMF)、适应性证书 (CEP) 和相关上市许可 (MA) 档案中说明。因此，如果注册信息有任何变更，则应通过适当的变更(CEP 或 MA)，并应立即将变更传达给任何使用该物料的成品制造商。
