近日，欧洲药品管理局EDQM-OMCL发布了新的质量管理文件《结果的评估和报告》，包含1个核心文件和5个附录（附录1 修约、附录2 定量测试结果的评估、附录3 OOS结果的确认、附录3.1 概述-初始OOS结果的确认、附录3.2 定量测试OOS结果的确认、附录3.3 定量测试OOS结果的确认、附录3.4：与OOS结果确认有关的动物试验的特殊考虑），内容包括如下：
1. Introduction
介绍
2. Scope
范围
3. Glossary and definitions (also used in the text of the Annexes)
术语和定义（也适用于附录文本）
4. Evaluation of testing results
测试结果评估
4.1 Testing results
测试结果
4.1.1 Pre-testing phase
预测试阶段
4.1.2. Testing phase
测试阶段
4.1.2.1. Method verification
方法确认
4.1.2.2. Generation of raw data for sample analysis
样品分析原始数据的生成
4.1.2.3. Review of the raw data
原始数据的审核
4.1.2.4. Calculation of the results
结果的计算
4.1.2.5. Averaging and Rounding of the results:
结果的平均和修约
4.1.2.6. Checking validity of results
结果的有效性检查
4.2 Ensuring validity of testing results (including monitoring and trending)
确保测试结果的有效性（包括监控和趋势）
4.3 Decision rules (as defined in ISO/IEC 17025:2017)
决策规则（定义见ISO/IEC 17025：2017）
4.4 Out-of-specification (OOS) results
OOS结果
4.4.1 Failure investigation of OOS results
OOS结果的调查
4.4.2 Retest programme for confirmation of OOS results
用于确认OOS结果的复测程序
4.5 Review and authorisation of testing results
测试结果的审核和批准
5. Reporting of results
结果的报告
6. References
参考文献
Annex 1. Rounding
附录1 修约
Annex 2. Evaluation of results from quantitative testing
附录2 定量测试结果的评估
Annex 3. Verification of OOS results
附录3 OOS结果的确认
Annex 3.1: General Introduction - Verification of Initial out-of-specification (OOS) results
附录3.1 概述-初始OOS结果的确认
Annex 3.2: Verification of OOS results in quantitative testing
附录3.2 定量测试OOS结果的确认
Annex 3.3: Verification of OOS results in qualitative testing
附录3.3 定量测试OOS结果的确认
Annex 3.4: Special considerations for animal testing in connection with verification of OOS results
附录3.4：与OOS结果确认有关的动物试验的特殊考虑
文件中指出，数据的平均取决于样本和所使用的方法。
Averaging of the data depends on the sample and the method used.
数据的平均取决于样本和所使用的方法。
Examples
示例
In the potentiometric determination of pH value, the reportable result is determined by calculating the average of a number (for example 3) of measurements of a sample, and this average is reported as the test result.
在pH值的电位测定中，通过计算样品测量值的平均值（例如3）来确定报告结果，并将该平均值报告为测试结果。
For an HPLC method for assay of active substance, one independent determination has been carried out by three consecutive injections (replicates) of the same sample preparation. The reportable result is determined by averaging the peak responses from these replicates obtained from the same preparation. The assay result is calculated using the peak response average. This determination is considered as one test and one reportable result, and should fulfil the predefined acceptable precision criteria, e.g. based on validation criteria.
对于用于测定活性物质的HPLC方法，已通过连续三次进针（重复）相同的样品溶液进行一次独立的测定。通过对从同一溶液中获得的这些重复的峰响应求平均值来确定可报告的结果。使用峰值响应平均值计算测定结果。该测定被视为一项测试和一个可报告的结果，并应满足既定的的可接受精度标准，例如基于验证标准。
同时也提出：
When evaluating results of microbiological contamination tests it is important to note that the contamination may not be distributed evenly throughout a product batch or sample. Homogeneity of a microbiological sample, for example, by thorough mixing prior to testing, does not imply a constant level of microbial cells throughout test sample units. Where the contamination is not uniformly distributed throughout a product batch or sample, i.e. contamination is detected in some but not all of the units, it may not be valid to pool and then average the count results from multiple units of the sample as this could average out a non-compliant result to a compliant result.
在评估微生物污染测试结果时，重要的是要注意污染可能不均匀地分布在整个产品批次或样品中。微生物样品的均匀性，例如，通过在测试前彻底混合，并不意味着整个测试样品单元的微生物细胞水平恒定。如果污染在整个产品批次或样品中分布不均匀，即在某些而非全部单位中检测到污染，则合并然后平均多个样品单位的计数结果可能无效，因为这可能会将不合格结果平均为合格结果。
