欧盟GMP附录8 起始物料与包装材料的取样

2. The identity o f a complete batch o f starting materials can normally only be ensured if individual samples are taken from all the containers and an identity test performed on each sample. It is permissible to sample only a proportion o f the containers where a validated procedure has been established to ensure that no single container o f starting material has been incorrectly labelled. 

通常，只有对每一个包装容器取样，并逐个样品进行鉴别后，才能确保整批起始物料鉴别无误。只 有建立了通过验证的规程，确保起始物料每一个包装容器标示正确，才允许仅对整批的一部分容器 进行取样。