美国药典检验方法确认.doc

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 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, equipment, and reagents available. This chapter is not intended for retroactive application to already successfully established laboratory procedures. The chapter Validation of Compendial Procedures 1225 provides 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 1225, to generate appropriate, relevant data rather than repeating the validation process. 本章节的目的是提供关于药典规程确认的信息，这些规程是第一次执行，利用可用的人员、设备和试剂，来生成可接受的结果。本章节不是为了对已经成功确立的实验室规程进行追溯操作。通则药典规程的验证1225提供了关于不同测试种类应当考虑的特性，以及应当生成文件连同分析操作规程一起提交给相关部门以便列入USP-NF（《美国药典/国家处方集》）。确认包括评估选定的分析工作特性，例如那些在通则1225中描述的，以生成适合、相关的数据，而不是重复验证程序。 ? 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.” 药典分析规程的使用者无需于规程在实验室中初次使用时验证这些规程，但是关于在实际使用条件下的适用性的证据应当以文件形式记录。在美国，这些要求在现行药品生产质量管理规范的21 CFR 211.194(a)(2)中有明确规定，文件声明“所有测试方法在实际使用条件下的适用性应当被确认。” ? Verification of microbial procedures is not covered in this chapter because it is covered in USP general chapters Antimicrobial Effectiveness 5