Sec. 211.84 原辅料、药品容器及密封件的检验、批准或拒绝 (a) 每批原辅料、药品容器和密封件，在质量管理部门完成适当的取样、检验或检查及放行使用前，应限制使用。(b) 应对每次运输到货的每批物料采集代表性样品，以供检验或检查。应根据适当的标准来确定容器抽样的件数，以及每个容器的取样量如：原辅料变异的统计学标准、置信水平、预期精确程度、供应商的过去质量史、 277.170要求的分析需用量及留样量(c) 样品按下列程序采集： (1) 必要时，对所选原辅料的容器进行清洁，应采用避免对原辅料引入污染物的方式。 (2) 包装容器的开启、取样和重新封口应按照防止内容物的污染以及其它原辅料、药品容器或密封件的污染的方式进行。(3) 必要时可应用灭菌设备和无菌取样技术。 (4) 如果需要从原辅料的顶部、中部和底部对原辅料进行取样，这些分样不应混合用于检验。(5) 样品容器应有标识，注明如下信息：所取物料名称、批号、被取容器、取样日期及样品采集人姓名。(6) 被取样的包装容器应做标记，表明其样品已取。
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ICH Q7A关于取样的要求：
7.33 Samples should be representative of the batch of material from which they are taken.
Sampling methods should specify the number of containers to be sampled, which part of the container to sample, and the amount of material to be taken from each container. The number of containers to sample and the sample size should be based upon a sampling plan that takes into consideration the criticality of the material, material variability, past quality history of the supplier, and the quantity needed for analysis.
7.34 Sampling should be conducted at defined locations and by procedures designed to prevent contamination of the material sampled and contamination of other materials.
7.35 Containers from which samples are withdrawn should be opened carefully and subsequently reclosed. They should be marked to indicate that a sample has been taken.
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