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
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, ... ...
<1226>: "Verification consists of assessing selected analytical performance characteristics, such as those that are described in chapter , to generate appropriate, relevant data rather than repeating the validation process." t , . . -.. ,i verification: FDA -1$ l.t5!tro*r,lirrd?$.4r ...
ty of a procedure under actual conditions of use, some of the analytical performance characteristics listed in chapter á1225ñ, Table 2, may be used for the verification process. Only those characteristics that are considered to be appropriate for the verifi- ...
16、 differ with respect to terminology and use, each of the performance characteristics is defined in the next section of this chapter, along with a delineation of a typical 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...
of each analytical per-and reagents available. This chapter is not intended for ret-formance characteristic.v USP35 The degree 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 ...
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 ...
美国药典35版USP 1225 VALIDATION OF COMPENDIAL PROCEDURES.pdf,Accessed from 46.201.206.156 by boyo3 on Wed May 16 18:53:54 EDT 2012 USP 35 General Information / 〈1225〉 Validation of Compendial Procedures 877 ELEMENTS RECOMMENDED FOR THE It is recomm
The United States Pharmacopeia's (USP) new chapter <63> Mycoplasma Tests(1) was intended to fill a void in the USP for mycoplasma testing, which had been addressed previously within the FDA's 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (PTC) and...
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...