l美国FDA分析方法验证指南中英文对照.docVIP

美国FDA分析方法验证指南中英文对照（二） 上一篇 / 下一篇 ?2009-01-05 10:44:15 / 个人分类：GMP/GLP 查看( 1076 ) / 评论( 2 ) / 评分( 0 / 0 ) III. TYPES OF ANALYTICAL PROCEDURES A. Regulatory Analytical Procedure A regulatory analytical procedure is the analytical procedure used to evaluate a defined characteristic of the drug substance or drug product. The analytical procedures in the U.S. Pharmacopeia/National Formulary (USP/NF) are those legally recognized under section 501(b) of the Food, Drug, and Cosmetic Act (the Act) as the regulatory analytical procedures for compendial items. For purposes of determining compliance with the Act, the regulatory analytical procedure is used. III　分析方法的类型 A. 法定分析方法 法定分析方法是被用来评估原料药或制剂的特定性质的。USP/NF中的分析方法是法定的用于药典项目检测的分析方法。为了确认符合法规，需使用法定分析方法。 B. Alternative Analytical Procedure An alternative analytical procedure is an analytical procedure proposed by the applicant for use instead of the regulatory analytical procedure. A validated alternative analytical procedure should be submitted only if it is shown to perform. equal to or better than the regulatory analytical procedure. B. 替代分析方法 替代分析方法是申请者提出用于代替法定分析方法的分析方法。只有当一替代分析方法相当于或优于法定分析方法时，才可以应用验证过的替代分析方法。 If an alternative analytical procedure is submitted, the applicant should provide a rationale for its inclusion and identify its use (e.g., release, stability testing), validation data, and comparative data to the regulatory analytical procedure.如果提交了替代分析方法，申请者还应当提供其理由，并标明其用途（如，放行，稳定性实验），验证资料及其与法定分析方法的对比资料。 C. Stability-Indicating Assay A stability-indicating assay is a validated quantitative analytical procedure that can detect the changes with time in the pertinent properties of the drug substance and drug product. C. 稳定性指示分析 稳定性指示分析是能检测出原料药或制剂的某些性质随着时间的延长而出现的变化的定量分析方法。 A stability-indicating assay accurately measures the active ingredients, without interference from degradation products, process impurities, excipients, or other potential impurities。 稳定性指示分析能不受降解产物，工艺杂质，赋形剂或其它潜在杂质的影响而准确测定其中的活性成分。 If an applicant