USP〈1225〉药典规程的验证(中英文对照)(16)

evaluation of robustness and ruggedness should be that a series of system suitability parameters is established to ensure that the validity of the analytical procedure is maintained whenever used. Typical variations are the stability of analytical solutions, different equipment, and different analysts. In the case of liquid chromatography, typical variations are the pH of the mobile phase, the mobile phase composition, different lots or suppliers of columns, the temperature, and the flow rate. In the case of gas chromatography, typical variations are different lots or suppliers of columns, the temperature, and the flow rate.

如果检测结果易受分析条件中的差异影响，则这些差异应当被适当地控制，或应当在规程中加入预防性的陈述。评估耐用性的一个结果就是确立一系列系统适用性参数，以确保不论何时使用，均可维持分析规程的有效性。典型的差异是分析溶液、不同设备、不同分析员的稳定性。对于液相色谱法而言，典型的差异是流动相pH值、流动相构成、不同批号或供应商的色谱柱、温度、流速。对于气相色谱法而言，典型差异是不同批号或供应商的色谱柱、温度、流速。

System suitability tests are based on the concept that the equipment, electronics, analytical operations, and samples to be analyzed constitute an integral system that can be evaluated as such. System suitability test parameters to be established for a particular procedure depend on the type of procedure being evaluated. They are especially important in the case of chromatographic procedures. Submissions to the USP should make note of the requirements under the System Suitability section in the general test chapter Chromatography <621>.

系统适用性测试基于这个概念，即这些设备、电子仪器、分析操作、供试样品构成了一个完整系统，此系统可以作为整体进行评估。为某个特定规程设定的系统适用性测试参数取决于被评估的规程的种类。对于色谱规程，它们尤其重要。向USP提交的文件应该应该注明在通则色谱法<621>中系统适用性章节下的要求。

Data Elements Required for Validation验证所需的数据要素

Compendial test requirements vary form highly exacting analytical determinations to subjective evaluation of attributes. Considering this broad variety, it is only logical that different test procedures require different validation schemes. This chapter covers only the most common categories of tests for which validation data should be required. These categories are as follows:

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