USP〈1225〉药典规程的验证(中英文对照)(4)

Linearity线性

Range范围

Robustness耐用性

In the case of compendial procedures, revalidation may be necessary in the following cases: a submission to the USP of a revised analytical procedure; or the use of an established general procedure with a new product or raw material (see below in Data Elements Required for Validation). 对于药典规程，在下面的情况下可能必需在验证：向USP提交修改的分析规程；或将已确立的通用规程用于新产品或原料（见下面验证必需的数据要素）

The ICH documents give guidance on the necessity for revalidation in the following circumstances: changes in the synthesis of the drug substance; changes in the composition of the drug product; and changes in the analytical procedure.

ICH文件对于下列情况下再验证的必要性做出了指导：原料药合成中的变更；成药组成中的变更；以及分析规程中的变更。

Analytical Performance Characteristics分析工作特性

ACCURACY准确度

Definition---- The accuracy of an analytical procedure is the closeness of test results obtained by that procedure to the true value. The accuracy of an analytical procedure should be established across its range.

定义---- 分析规程的准确度是由该规程得到的测试结果与真实值的接近程度。分析规程的准确度应该在其整个范围内得到确立。

Determination---- In the case of the assay of a drug substance, accuracy may be determined by application of the analytical procedure to an analyte to known purity (e.g., a Reference Standard) or by comparison of the results of the procedure with those of a second, well-characterized procedure,

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