USP401226药典的确认中英文对照

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 ava

2、ilable.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 alreadysuccessfully established laboratory procedures. The chapterValidation ofCompendial Procedures <1225>provides general information oncharacteristics that should be cons

3、idered 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 inchapter < 1225> to generate appropri

4、ate, 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 l

5、aboratories, 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 us

6、ed 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 CFR211.194(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 chapterbecause it is covered in USP general chaptersAntimicrobi

7、alEffectiveness < 51>, Microbiological Examination of Nonsterile Products:Microbial Enumeration Tests61, Microbiological Examination ofNonsterile Products: Tests for Specified Microorganisms62, SterilityTests 71, and Validation of Microbial Recovery from PharmacopeialArticles 1227.此章节，不包括微生物方法

8、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

9、 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

10、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。If the verification of the compendial procedure is not successful, and assistance from US

11、P staff has not resolved the problem, it may be concluded that the procedure may not be suitable for use with the article being tested in that laboratory. It may then be necessary to develop and validate an alternate procedure as allowed in the General Notices . The alternate procedure may be submit

12、ted to USP, along with the appropriate data, to support a proposal for inclusion or replacement of the current compendial procedure.如果药典方法的确认不成功，以及来自USP 职员的帮助未能解决问题，可以得出结论方法不适用。 有必要开发和验证替代的方法。替代的方法可以递交至USP ，附上适当的数据，以支持包括或取代当前药典方法的建议。VERIFICATION REQUIREMENTS确认的要求Verification requirements should be b

13、ased on an assessment of the complexity of both the procedure and the material to which the procedure is applied.确认要求应基于方法和方法所分析的物质的复杂性。Although complete revalidation of a compendial method is not required to verify the suitability of a procedure under actual conditions of use, some of theanalytical

14、 performance characteristics listed in chapter1225, Table2, may be used for the verification process.尽管在实际使用条件下， 不要求对药典方法的进行完整再验证来确认方法的适用性，一些在 <1226> 中列出的分析性能参数（表格2），可用于确认的过程。Only those characteristics that are considered to be appropriate for the verification of the particular method need to

15、be evaluated. The process of accessing the suitability of a compendial analytical test procedure under the conditions of a actual use may or may not require actual laboratory performance of each analytical performance characteristic. The degree and;.extent of the verification process may depend on t

16、he level of training and experience of the user, on the type of procedure and its associated equipment or instrumentation, on the specific procedural steps, and on which article(s) are being tested.那些被认为是适用于特定方法确认的参数需要评估。评估在实际使用条件下药典分析检测方法使用的过程可能需要也可能，也可能不需要实际实验室性能的分析性能特征。确认过程的深度和广度取决于培训水平和使用者使用此种方法

17、和使用相关设备或仪器，对特定方法步骤，对检测何种物质的经验。Verification should assess whether the compendialAs an example, an assessment of specificity is a key parameter in verifying that a compendial procedure is suitable for use in assaying drug substances and drug products. For instance, acceptable specificity for a chromat

18、ographic method may be verified by conformance with system suitability resolution requirements (if specified in the method).例如，专属性的评估是确认药典方法适用于含量测定原料药和制剂的关键参数。例如，色谱方法的可接受的专属性可以通过符合系统适应性分离度要求来确认（如在方法中指明）。However, drug substances from different suppliers may have different impurity profiles that are n

19、ot addressed by the compendial test procedure. Similarly, the excipients in a drug product can vary widely among manufacturers and may have the potential to directly interfere with the procedure or cause the formation of impurities that are not addressed by the compendial procedure. In addition, dru

20、g products containing different excipients, antioxidants, buffers, or container extractives, may potentially interfere with the compendial procedure.然而，不同供应商的原料药可能有不同的杂质情况，这些未用药典方法进行叙述。类似的，制剂中赋形剂制造商中可能有广泛的不同，可能会直接影响方法或导致药典中未叙述杂质的形成。此外，制剂中含有不同的赋形剂，抗氧剂，缓冲剂，或容器萃取剂，可能对药典方法有潜在的影响。;.In these cases, a more

21、 thorough assessment of specificity may be required to demonstrate suitability of the method for the particular drug substance or product. Other analytical performance characteristics such as an assessment of the limit of detection or quantitation and precision for impurities procedures may be usefu

22、l to demonstrate the suitability of the compendial method under actual conditions of use.这些情况下，要求对专属性性更为彻底的评估以证明方法适用于特定的原料药或制剂。其它的分析性能参数如杂质检测限或定量限以及精密度的评估对证明药典方法在实际的使用条件下适用也是很有用的。Verification is not required for basic compendial test procedures that are routinely performed unless there is an indication that the compendial procedure is not appropriate for the article under test. Examples of basic compendial procedures include, but are not limited to, loss on drying, residue on ignition, various wet chemical procedures such as acid value, and simple instrumental methods such as pH m