USP401226药典的确认中英文对照

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 <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.

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 Tests 71, and Validation of Microbial Recovery from Pharmacopeial Articles 1227.

此章节，不包括微生物方法的确认。因为微生物检测方法包含在抗菌效果<51>、有菌产品的微生物检测：微生物枚举测试<61>、有菌产品的微生物检测：特定微生物的检测<62>、无菌检查<71>、微生物复苏验证<1227> VERIFICATION PROCESS

确认的过程

The verification process for compendial test procedures is the assessment of whether the procedure can be used for its intended purpose, under the actual conditions of use for a specified drug substance and/or drug product matrix.

药典检测方法的确认过程是评估方法是否可用于其预期的目的,在实际条件下使用指定的药用物质和/或药物产品的矩阵。

Users should have the appropriate experience, knowledge, and training to understand and be able to perform the compendial procedures as written. Verification should be conducted by the user such that the results will provide confidence that the compendial procedure will perform suitably as intended.

使用者应有适当的经验、知识和培训来了解和能够演示药典方法。使用者所做的确认，应是提供了证据：能够证明药典方法能够如预期一样顺利演示。