USP401226药典的确认中英文对照.pdf,. 1226 VERIFICATION OF COMPENDIAL PROCEDURES 药典方法的确认 The intent of this general information chapter is to provide general information on the verification of compendial procedures that are being performed for the f
<1226>VERIFICATIONOFCOMPENDIALPROCEDURES 药典规程的确认 Theintentofthischapteristoprovidegeneralinformationontheverificationofcompendial proceduresthatarebeingperformedforthefirsttimetoyieldacceptableresultsutilizingthepersonnel, equipment,andreagentsavailable.Thischapterisnotintendedforretroactiveapplicationtoalready ...
可以参考。 <1226> VERIFICATION OF COMPENDIAL PROCEDURES 药典规程的确认 The intent of this chapter is to provide general information on the verification of compendial procedures that are being performed for the first time to yield acceptable results utilizing the personnel, ... ...
Theintentofthisgeneralinformationchapteristoprovidegeneralinformationontheverificationofcompendialprocedures thatarebeingperformedforthefirsttimetoyieldacceptableresultsutilizingthepersonnel,equipment,andreagentsavaila- ble.Thischapterisnotintendedforretroactiveapplicationtoalreadysuccessfullyestablishedlaboratoryprocedures.Thechap...
1、1226 VERIFICATION OF COMPENDIAL PROCEDURES药典方法的确认The intent of this general information chapter is to provide general information on the verification of compendial procedures that are being performed for the first time to yield acceptable results utilizing the personnel, equipment, and reagents ...
and extent of the roactive application to already successfully established labo-verification process may depend on the level of training and ratory procedures. The chapter Validation of Compendial Pro-experience of the user, on the type of procedure and its cedures 〈1225〉 provides general ...
16、pect to terminology and use, each of the performance characteristicsis defined in the next section of this chapter, along with a delineation of atypical method or methods by which it may be measured.分析规程的验证是,通过实验室研究,确定该规程的工作特性达到了预定分析用途要求的过程。在此文件中...
见1226。适当的文件应和新的或修改后的法定的方法一致。 Auxiliary Information— Please? check for your question in the FAQs?before contacting USP. 辅助信息——在联系USP前请核对FAQ中你们的问题 Topic/Question 话题/问题 Contact 联系 Expert Committee 专家委员会 General Chapter 总章节 Horacio N. Pappa, ...
guidance for 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...
8. Ful l val idation data are not necessary for compendial tests where there is a USP–NFmonograph. However,data verifying the suitabi l ity of the compendial procedure for the manufacturer’s excipient must be included in the package (see draft General Chapter<1226>Verification of Compendial...