System suitability tests are based on the concept that the equipment, electronics, analytical operations, and samples to be analyzed constitute an integral system that can be evaluated as such. System suitability test parameters to be established for a particular procedure depend on the type of procedure being evaluated. They are especially important in the case of chromatographic procedures. Submissions to the USP should make note of the requirements under the System Suitability section in the general test chapter Chromatography <621>.
系统适用性测试基于这个概念，即这些设备、电子仪器、分析操作、供试样品构成了一个完整系统，此系统可以作为整体进行评估。为某个特定规程设定的系统适用性测试参数取决于被评估的规程的种类。对于色谱规程，它们尤其重要。向USP提交的文件应该应该注明在通则色谱法<621>中系统适用性章节下的要求。
Data Elements Required for Validation验证所需的数据要素
Compendial test requirements vary form highly exacting analytical determinations to subjective evaluation of attributes. Considering this broad variety, it is only logical that different test procedures require different validation schemes. This chapter covers only the most common categories of tests for which validation data should be required. These categories are as follows: 药典测试的要求差别较大，从高度精确的分析测定到特性的主观评估。考虑到此宽幅差异，则可以理解不同测试规程需要不同的验证计划。此章节仅覆盖了这些需要验证数据的测试中最常见的种类。这些种类如下：
Category I---- Analytical procedures for quantitation of major components of bulk drug substances or active ingredients (including preservatives) in finished pharmaceutical products.
第一类：对成药中原料药或活性成分（包括防腐剂）的主要组分进行定量测定的分析规程。
Category II---- Analytical procedures for determination of impurities in bulk drug substances or degradation compounds in finished pharmaceutical products. These procedures include quantitative assays and limit tests.
第二类：对成药中原料药或降解物质中杂质进行测定的分析规程。这些规程包括定量测定和限度测定。
Category III---- Analytical procedures for determination of performance characteristics (e.g., dissolution, drug release).
第三类：对工作特性（例如，溶出度、药物释放）进行测定的分析规程。
Category IV---- Identification tests. 第四类：鉴别测试。
For each category, different analytical information is needed. Listed in Table 2 are
data elements that are normally required for each of these categories. 每一个类别均需要不同的分析信息。每个种类通常所需要的数据要素在表2中列出。
Table 2. Data Elements Required for Validation
Analytical Performance Characteristics Accuracy Precision Specificity Detection Limit Quantitation Limit Linearity Range
Category I Yes Yes Yes No No Yes Yes
Category II Quantitative
Yes Yes Yes No Yes Yes Yes
Limit Tests * No Yes Yes No No *
Category III
* Yes * * * * *
Category IV
No No Yes No No No No
*May be required, depending on the nature of the specific test.
表2. 验证必需的数据要素
分析工作特性 准确度 精密度 专属性 检测限度 定量限度 线性 范围
第一类 是 是 是 否 否 是 是
是 是 是 否 是 是 是
第二类
定量测试
限度测试
* 否 是 是 否 否 *
第三类 * 是 * * * * *
第四类 否 否 是 否 否 否 否
可能需要，取决于具体测试的特性
Already established general procedure (e.g., titrimetric determination of water, bacterial endotoxins) should be ▲verified to establish their suitability for use, such as▲USP31 their accuracy (and absence of possible interference) when used for a new product or raw material.
已经确立的通用规程（例如，水分滴定测定、细菌内毒素）应当▲进行确认，以确立在用于新的产品或原料时的适用性，例如▲USP31其准确度（和无可能的干扰因素）。
The validity of an analytical procedure can be verified only by laboratory studies. Therefore, documentation of the successful completion of such studies is a basic requirement for determining whether a procedure is suitable for its intended application(s). Current compendial procedures are also subject to regulations that require demonstration of suitability under actual conditions of use ▲(see Verification of Compendial Procedures <1226> for principles relative to the verification of compendial procedures). ▲USP31 Appropriate documentation should accompany any
proposal for new or revised compendial analytical procedures. 分析规程的有效性可以通过实验室研究来确认。因此，此类研究成功完成的记录文件是确定某个规程是否适用于其预定用途的基本要求。当前的药典规程也要符合相关管理规定，要证实在实际使用条件下的适用性。▲（见药典规程的确认<1226>，以了解与药典规程确认相关的基本原则）▲USP31适当的记录文件应伴随着任何有关新的或修改过的药典分析规程的方案。
<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，使用可用的人员、设备、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，以及应当伴随为成为法定程序而递交给USP-NF的申请文件中的记录文件的相关信息。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，这些要求在药品优良生产规范的21 CFR 211.194(a)(2)中规定，文件声明“所有测试方法在实际使用条件下的适用性将被确认。”
Verification of microbial procedures is not covered in this chapter because it is covered in USP general chapters Antimicrobial Effectiveness <51>, Microbiological
Examination of Non-sterile Products: Microbial Enumeration Tests <61>, Microbiological Examination of Non-sterile products: Tests for Specified Microorganisms<62>, Sterile Tests <71>, and Validation of Microbial Recovery from Pharmaceutical Articles<1227>.
微生物规程的确认方法不在此章节内，因为其由以下USP通则涵盖：抗菌效力<51>、非无菌产品的微生物学检查：微生物计数测试<61>、非无菌产品的微生物学检查：规定微生物的测试<62>、无菌测试<71>、药物微生物回收的验证<1227>。
VARIFICATION PROCESS确认程序
Users should have the appropriate experience, knowledge, and training to understand and be able to perform the compendial procedure 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.
使用者应该有适当的经验、知识、培训，以理解和能够执行书面的药典规程。确认应当由使用者进行，其结果将提供该药典规程会如预期的一样适当表现的信心。
If the verification of the compendial procedure is not successful, and assistance from USP 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 submitted to USP, along with the appropriate data, to support a proposal for inclusion or replacement of the current compendial procedure.
如果药典规程的确认不成功，并且USP员工的协助也未能解决问题，则可断定此规程不适合在此实验室用于供试物品。然后，可能必须按照凡例中所说开发和验证替代规程。此替代规程可以与适当的数据仪器提交给USP，以支持将其加入或取代当前药典规程的方案。
VERFICATION REQUIREMENTS确认要求
Verification requirements should be based on an assessment of the complexity of both the procedure and the material to which the procedure is applied. Although complete revalidation of a compendial method is not required to verify the suitability of the method under actual conditions of use, some of the analytical performance characteristics listed in chapter <1225>, Table 2, may be used for the verification process. Only those characteristics that are considered to be appropriate for the verification of the particular method need to be evaluated. The degree and extent of the verification process may depend on the 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.
确认要求应该基于对此规程和要应用此规程的物质的复杂性进行的评估。虽然无
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