verification of compendial procedures that are being performed for the first time to yield acceptable results utilizing the personnel, equipment, and reagents available. This chapter is not intended for retroactive application to already successfully established laboratory procedures. The chapter Validation ...
USP 通则 61 62 71 1225 1226因为对于术语和使用的意见可能不同在此通则的下个部分定义了每个工作性能以及可以对其进行测量的常用的一个或几个方法的描typicalanalyticalcharacteristicsusedmethodvalidation在方法验证中使用的常用分析特性accuracy准确度precision精密度specificity专属性detectionlimit检测限度quantitationlimit定量...
SpecifiedMicroorganisms<62>,SterileTests<71>,andValidationofMicrobialRecoveryfrom PharmaceuticalArticles<1227>. 微生物规程的确认方法不在此章节内,因为其由以下USP通则涵盖:抗菌效力<51>、非无菌产品的 微生物学检查:微生物计数测试<61>、非无菌产品的微生物学检查:规定微生物的测试<62>、无菌测试 ...
在1226中列出的分析性能参数〔表格2〕,可用于确认的过程。 Only those characteristics that are considered to be appropriate for the verification of the particular method need to be evaluated. The process of accessing the suitability of a compendial analytical test procedure under the conditions of a ...
Each organism to be used in the test must be included in the validation. The preparation of the inoculum of challenge microorganisms also affects the testing of products having antimicrobial prop- erties. The growth and preparation of the challenge organism determines the physiological state of the...
USP 通则 61 62 71 1225 1226教程文件.doc,1225VALIDATION OF COMPENDIAL PROCEDURES 药典规程的验证 Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal F
01方法验证(Validation of method) USP:方法验证是一个通过实验室研究来证明程序的性能参数符合期望的分析应用要求的过程。 ICH:分析方法验证的目的是显示分析方法适用于它所期望的应用目的。 FDA:方法验证是一个阐述分析方法适合于其使用目的的过程。 02方法确认(Verification of method) ...
Table 1. Typical Analytical Characteristics Used in Method Validation表1. 在方法验证中使用的常用分析特性Accuracy准确度Precision精密度Specificity专属性Detection Limit检测限度Quantitation Limit定量限度Linearity线性Range范围Robustness耐用性In the case of compendial procedures, revalidation may b 18、e necessary ...
最新USP 通则 61 62 71 1225 1226<1225>VALIDATION OF COMPENDIAL PROCEDURES 药典规程的验证 Test procedures for assessment of the quality levels of pharmaceuticalarticlesare subject to various requirements.According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in...
14、ay be used fortheverificationprocess.尽管在实际使用条件下, 不要求对药典方法的进行完整再验证来确认方法的适用性,一些在 <1226>中列出的分析性能参数(表格2),可用于确认的过程。Only those characteristics that are considered to be appropriate for the verification of the particular method need to be ...