每一批生产中所有关键工艺步骤要设定足够的取样与控制，以保证每一批的操作是令人满意的。
Adequate sampling and controls are set for all the critical process steps for each product to ensure that each operation is satisfactory.
应在处理过程中的每个步骤之后以及每个用点处进行取样。
Sampling should be performed after each step in the treatment process and from each point of use.
溶出步骤是指药物在溶出介质中的释放和取样，分析方法的定义详见第3章节分析方法。
The dissolution step is the release of the drug inthe dissolution medium and sampling. The analytical finish is defined insection 3.
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