近日，歐洲藥品管理局EDQM-OMCL發(fā)布了新的質(zhì)量管理文件《結(jié)果的評(píng)估和報(bào)告》，包含1個(gè)核心文件和5個(gè)附錄（附錄1 修約、附錄2 定量測(cè)試結(jié)果的評(píng)估、附錄3 OOS結(jié)果的確認(rèn)、附錄3.1 概述-初始OOS結(jié)果的確認(rèn)、附錄3.2 定量測(cè)試OOS結(jié)果的確認(rèn)、附錄3.3 定量測(cè)試OOS結(jié)果的確認(rèn)、附錄3.4：與OOS結(jié)果確認(rèn)有關(guān)的動(dòng)物試驗(yàn)的特殊考慮），內(nèi)容包括如下：
1. Introduction
介紹
2. Scope
范圍
3. Glossary and definitions (also used in the text of the Annexes)
術(shù)語(yǔ)和定義（也適用于附錄文本）
4. Evaluation of testing results
測(cè)試結(jié)果評(píng)估
4.1 Testing results
測(cè)試結(jié)果
4.1.1 Pre-testing phase
預(yù)測(cè)試階段
4.1.2. Testing phase
測(cè)試階段
4.1.2.1. Method verification
方法確認(rèn)
4.1.2.2. Generation of raw data for sample analysis
樣品分析原始數(shù)據(jù)的生成
4.1.2.3. Review of the raw data
原始數(shù)據(jù)的審核
4.1.2.4. Calculation of the results
結(jié)果的計(jì)算
4.1.2.5. Averaging and Rounding of the results:
結(jié)果的平均和修約
4.1.2.6. Checking validity of results
結(jié)果的有效性檢查
4.2 Ensuring validity of testing results (including monitoring and trending)
確保測(cè)試結(jié)果的有效性（包括監(jiān)控和趨勢(shì)）
4.3 Decision rules (as defined in ISO/IEC 17025:2017)
決策規(guī)則（定義見(jiàn)ISO/IEC 17025：2017）
4.4 Out-of-specification (OOS) results
OOS結(jié)果
4.4.1 Failure investigation of OOS results
OOS結(jié)果的調(diào)查
4.4.2 Retest programme for confirmation of OOS results
用于確認(rèn)OOS結(jié)果的復(fù)測(cè)程序
4.5 Review and authorisation of testing results
測(cè)試結(jié)果的審核和批準(zhǔn)
5. Reporting of results
結(jié)果的報(bào)告
6. References
參考文獻(xiàn)
Annex 1. Rounding
附錄1 修約
Annex 2. Evaluation of results from quantitative testing
附錄2 定量測(cè)試結(jié)果的評(píng)估
Annex 3. Verification of OOS results
附錄3 OOS結(jié)果的確認(rèn)
Annex 3.1: General Introduction - Verification of Initial out-of-specification (OOS) results
附錄3.1 概述-初始OOS結(jié)果的確認(rèn)
Annex 3.2: Verification of OOS results in quantitative testing
附錄3.2 定量測(cè)試OOS結(jié)果的確認(rèn)
Annex 3.3: Verification of OOS results in qualitative testing
附錄3.3 定量測(cè)試OOS結(jié)果的確認(rèn)
Annex 3.4: Special considerations for animal testing in connection with verification of OOS results
附錄3.4：與OOS結(jié)果確認(rèn)有關(guān)的動(dòng)物試驗(yàn)的特殊考慮
文件中指出，數(shù)據(jù)的平均取決于樣本和所使用的方法。
Averaging of the data depends on the sample and the method used.
數(shù)據(jù)的平均取決于樣本和所使用的方法。
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值的電位測(cè)定中，通過(guò)計(jì)算樣品測(cè)量值的平均值（例如3）來(lái)確定報(bào)告結(jié)果，并將該平均值報(bào)告為測(cè)試結(jié)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.
對(duì)于用于測(cè)定活性物質(zhì)的HPLC方法，已通過(guò)連續(xù)三次進(jìn)針（重復(fù)）相同的樣品溶液進(jìn)行一次獨(dú)立的測(cè)定。通過(guò)對(duì)從同一溶液中獲得的這些重復(fù)的峰響應(yīng)求平均值來(lái)確定可報(bào)告的結(jié)果。使用峰值響應(yīng)平均值計(jì)算測(cè)定結(jié)果。該測(cè)定被視為一項(xiàng)測(cè)試和一個(gè)可報(bào)告的結(jié)果，并應(yīng)滿(mǎn)足既定的的可接受精度標(biāo)準(zhǔn)，例如基于驗(yàn)證標(biāo)準(zhǔn)。
同時(shí)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.
在評(píng)估微生物污染測(cè)試結(jié)果時(shí)，重要的是要注意污染可能不均勻地分布在整個(gè)產(chǎn)品批次或樣品中。微生物樣品的均勻性，例如，通過(guò)在測(cè)試前徹底混合，并不意味著整個(gè)測(cè)試樣品單元的微生物細(xì)胞水平恒定。如果污染在整個(gè)產(chǎn)品批次或樣品中分布不均勻，即在某些而非全部單位中檢測(cè)到污染，則合并然后平均多個(gè)樣品單位的計(jì)數(shù)結(jié)果可能無(wú)效，因?yàn)檫@可能會(huì)將不合格結(jié)果平均為合格結(jié)果。
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