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21cfr211中英文对照版(smart)

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nd bottom of its container, such sampleР 样品不得混合。Рsubdivisions shall not posited for testing.Р(5) Sample containers shall be identified so that theРfollowing information can be determined: name of the (5)标识样品容器,目的是确定如下资料:被取样的材料名Рmaterial sampled, the lot number, the container from 称、批号、被取样的容器,取样日期及样品收集人的名字等Рwhich the sample was taken, the date on which the 。Рsample was taken, and the name of the person whoР(6) Containers from which samples have been takenРshall be marked to show that samples have been (6)已取样的容器,应作标志,表示样品已取出。Рremoved from them.Р(d) Samples shall be examined and tested as follows: (d)样品检验程序:Р(1) At least one test shall be conducted to verify theР (1)一个药品的每个成分,最少做一个特性试验。如有专一Рidentity of ponent of a drug product. SpecificР 特性实验就应采用。Рidentity tests, if they exist, shall be used.

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