Is it necessary for the source of any peptone used (e.g. animal or vegetable origin) in the fermentation process for the production of active substances to be included in relevant dossiers?
如果原料药生产的发酵工艺中使用了蛋白胨（例如动物和植物来源），是否需要放在相关注册资料中？
1 回答
Yes. Peptone is considered to be a critical raw material, whose origin (animal or vegetable) and source (supplier name and address) should be specified in any Active Substance Master File (ASMF), Certificate of Suitability (CEP) and where relevant Marketing Authorisation (MA) dossiers. Consequently, if there is any change to the registered information, the change should be sought by appropriate variation (CEP or MA) and for transparency and to ensure relevant responsibilities are adhered to, the change should be immediately communicated to any finished product manufacturer who uses the material.
需要。蛋白胨是一种关键原料，其来源（动物或植物）和供应（供应商名称和地址）应在ASMF、CEP和相关MA注册资料中写明。之后，如果对注册信息有任何变更，应通过适当的程序申报变更（CEP或MA），应确保履行相关义务，立即将变更通知给使用该原料的制剂生产商。
