1.1 本规程提供了一种评估单阶段或多阶段验收程序的通用方法，该程序涉及在数值尺度上测量的质量特性。该方法在规定的置信水平下，使用抽样总体测试结果分布参数的估计值，计算通过验收程序的概率下限。 1.2 对于规定的概率下限，该方法还可以生成验收极限表，该表定义了一组测试方法结果（例如，样本平均值和标准偏差），这些结果将在规定的置信水平下通过验收程序。 1.3 该方法可用于证明符合过程中、验证或批次- 发布规范。 1.4 没有具体说明这种做法的单位制。 1.5 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ===意义和用途====== 4.1 本规程考虑了可能涉及多个- 阶段采样，在每个阶段，可以决定接受或继续采样，拒绝的决定推迟到最后阶段。 4.1.1 在每个阶段，测试结果都有一个或多个验收标准；例如，对每个单独测试结果的限制，或对基于测试结果样本的统计的限制，例如平均值、标准差或变异系数（相对标准差）。 4.2 该实践中的方法为抽样总体的一组测试结果定义了一个接受区域，使得在规定的置信水平下，总体样本通过接受程序的概率大于或等于预先指定的下限。 4.2.1 测试结果在验收范围内并不等同于通过验收程序，而是保证样品以特定的概率通过验收程序。 4.2.2 这些信息可用于工艺演示、测试方法验证以及仪器、工艺和材料的鉴定。 4.2.3 该信息可用于批量发布（验收），但在某些情况下，下限可能是保守的。 4.2.4 如果将结果应用于同一过程的未来测试结果，则假设该过程是稳定和可预测的。如果不是这种情况，那么就不能保证概率估计是对未来工艺性能的有效预测。 4.3 此方法最初是开发的 ( 1- 4. ) 3. 用于制药行业药品的两个特定质量特征，但适用于所有行业的验收程序。 4.4 每项测试的个别标准都需要数学推导。

1.1 This practice provides a general methodology for evaluating single-stage or multiple-stage acceptance procedures which involve a quality characteristic measured on a numerical scale. This methodology computes, at a prescribed confidence level, a lower bound on the probability of passing an acceptance procedure, using estimates of the parameters of the distribution of test results from a sampled population. 1.2 For a prescribed lower probability bound, the methodology can also generate an acceptance limit table, which defines a set of test method outcomes (for example, sample averages and standard deviations) that would pass the acceptance procedure at a prescribed confidence level. 1.3 This approach may be used for demonstrating compliance with in-process, validation, or lot-release specifications. 1.4 The system of units for this practice is not specified. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 This practice considers inspection procedures that may involve multiple-stage sampling, where at each stage one can decide to accept or to continue sampling, and the decision to reject is deferred until the last stage. 4.1.1 At each stage there are one or more acceptance criteria on the test results; for example, limits on each individual test result, or limits on statistics based on the sample of test results, such as the average, standard deviation, or coefficient of variation (relative standard deviation). 4.2 The methodology in this practice defines an acceptance region for a set of test results from the sampled population such that, at a prescribed confidence level, the probability that a sample from the population will pass the acceptance procedure is greater than or equal to a prespecified lower bound. 4.2.1 Having test results fall in the acceptance region is not equivalent to passing the acceptance procedure, but provides assurance that a sample would pass the acceptance procedure with a specified probability. 4.2.2 This information can be used for process demonstration, validation of test methods, and qualification of instruments, processes, and materials. 4.2.3 This information can be used for lot release (acceptance), but the lower bound may be conservative in some cases. 4.2.4 If the results are to be applied to future test results from the same process, then it is assumed that the process is stable and predictable. If this is not the case then there can be no guarantee that the probability estimates would be valid predictions of future process performance. 4.3 This methodology was originally developed ( 1- 4 ) 3 for use in two specific quality characteristics of drug products in the pharmaceutical industry but will be applicable for acceptance procedures in all industries. 4.4 Mathematical derivations would be required that are specific to the individual criteria of each test.