本帖最后由 beiwei5du 于 2017-8-5 11:36 编辑
关于配料分料后的标识,FDA CGMP。对于标识还有专门的要求,至少包括: (b) Components for drug product manufacturing shall be weighed, measured, or subdivided as appropriate. If a component is removed from the original container to another, the new container shall be identified with the following information: (1) Component name or item code;(物料的名称或者编码) (2) Receiving or control number;(接受或控制编号,这个一般指的内部给的批号) (3) Weight or measure in new container;(在新容器重量或者其他的测量) (4) Batch for which component was dispensed, including its product name, strength, and lot number.(已份物料最终要使用到的产品批号,包括产品名称,含量规格,批号) 所以如此多的信息,制定相应的标签就是很有必要的呢!并且这个配料标签/分料标签的设计应该和一般的物料标示有一定的区分。 |