检验方法确认美国药典usp1226 Verification ：确认。 针对使用法定方法(注意: 需要严格遵守方法要求，参数, 试剂, 标准品, 步骤等等), 需要在目前实验室的条件下确认是否可以获得可靠结果. 不一定是全部项目的验证，FDA针对常州SPL肝素钠的警告信中就有关于方法确认的内容. 可以参考。 <1226> VERIFICATION OF ...
VERIFICATIONREQUIREMENTS Verificationrequirements should be based on an assessment of the complexity of both the procedure and the material to which the procedure is applied. Although complete revalidation of a compendial method is not required to verify the suitabili- ty of a procedure under actual ...
Verification requirements should be based on an assessment of the complexity of both the procedure and the material to which the procedure is applied. Although complete revalidation of a compendial method is not required to verify the suitability of the method under actual conditions of use, ...
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 ...
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 ...
Other analytical performance characteristics such as an assessment of the limit of detection or quantitation and precision for impurities procedures may be useful to demonstrate the suitability of the compendial method under actual conditions of use. Verification is not required for basic compendial test ...
02方法确认(Verification of method) USP<1225>:USP-NF所收载方法的使用者不需要验证这些方法的准确性和可靠性,但需要确认这些方法在实际使用条件下的适应性。 USP<1226>:确认包括所涉及方法的性能参数,如那些在<1225>中描述的,以建立恰当的、相应的数据,而不是重复验证的过程。
Whatever method is used, the detection limit should be subsequently validated by the analysis of a suitable number of samples known to be near, or prepared at, the detection limit. 对于展示出背景噪音的仪器分析规程,ICH文件描述了一个通用方法,用来比较从以下样品测得的信号,这些样品分别为含已知低...
UsedinMethodValidation Accuracy Precision Specificity DetectionLimit QuantitationLimit Linearity Range Robustness Inthecaseofcompendialprocedures,revalidationmaybenecessaryinthefollowingcases:asubmissiontotheUSPofarevisedanalyticalprocedure;ortheuseofanestablishedgeneralprocedurewithanewproductorrawmaterial(seebelowinDataEleme...
generation of data (i.e., qualification, validation, and verification) in support of compendial analytical procedures. While the concepts presented in the proposed chapter are related to the verification processes described in general chapter Verification of Compendial Procedures 1226 , the verification ...