211.196 Distribution records.
Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers.
请问,为什么医用压缩气体不需要在记录上写明批号或者控制号码啊??
是不是因为生产工艺的特殊性,他的生产工艺是连续的,不便确定批号啊?
请了解的战友帮助。
Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers.
请问,为什么医用压缩气体不需要在记录上写明批号或者控制号码啊??
是不是因为生产工艺的特殊性,他的生产工艺是连续的,不便确定批号啊?
请了解的战友帮助。