USP40 1226 药典的确认中英文对照.docVIP

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 available. 此章节的意图是对药典方法的确认提供基本资料，使用人员，设备和试剂使第一次进行运用药典方法以产生可接受的结果。 This chapter is not intended for retroactive application to already successfully established laboratory procedures. The chapter?Validation of Compendial Procedures 1225provides general information on characteristics that should be considered for various test categories and on the documentation that should accompany analytical procedures submitted for inclusion in?USP–NF.?Verification consists of assessing selected analytical performance characteristics, such as those that are described in chapter?1225to generate appropriate, relevant data rather than repeating the validation process. 此章节并不旨在对已经成功建立的实验室方法进行回顾性运用。章节〈1225〉药典方法的验证对各种不同检测类别需要考虑的特征以及伴随分析方法的文件给出了基本资料。确认包括评估选择的分析性能特征，在〈1225〉叙述，以产生相关的数据而不是重复验证过程。 Users of compendial analytical procedures are not required to validate these procedures when first used in their laboratories, but documented evidence of suitability should be established under actual conditions of use. In the United States, this requirement is established in 21 CFR 211.194(a)(2) of the current Good Manufacturing Practice regulations, which states that the “suitability of all testing methods used shall be verified under actual conditions of use.” 不要求药典分析方法的使用者验证实验室第一次使用的方法，但需要具备在实际使用条件下的适用性证明文件。在美国，此要求确立在CGMP21 CFR 211.194(a)(2)中，其说明了在实际使用条件下所有使用的的检测方法的适用性应确认。 Verification of microbiological procedures is not covered in this chapter because it is covered in USP general chapters?Antimicrobial Effectiveness?51,?Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests?61,?Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms?62,?Sterility