【正文】 orming the validation負(fù)責(zé)方法確認(rèn)的人員可以得到 ? Up to date及時(shí)更新 ? Descriptive 敘述 ? Includes technical references, as appropriate適當(dāng)時(shí) ,包括專業(yè)參考文獻(xiàn) 27 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Personnel人員 Senior Ramp。 may also refer to precision between different laboratories)精密度包括重復(fù)性（短時(shí)間內(nèi)同一操作人員及相同條件下）和復(fù)現(xiàn)性（不同分析人員、不同工作日、不同操作條件、多指不同實(shí)驗(yàn)室間的精密度） 55 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Precision精密度 Precision is expressed at each calibration level by calculating the %CV (standard deviation / mean value) x 100在每一校準(zhǔn)水平下精密度通過(guò)相對(duì)標(biāo)準(zhǔn)偏差計(jì)算得到 The required level of precision may be specified in the reference method or by the customer所需的精密度水平可在參考方法中或顧客規(guī)定 Typically, acceptable precision is less than 15% CV (20 % at the LOQ)一般 CV小于 15% (LOQ水平為 20 % ) 56 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Robustness Testing 穩(wěn)健度試驗(yàn) Examination of the behavior of an analytical process when small changes in the environment or operating conditions are made在環(huán)境或操作條件小的改變下，對(duì)分析過(guò)程的表現(xiàn)的檢查 57 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Benefits of Robustness Testing 穩(wěn)健度試驗(yàn)的益處 Identification of critical control points關(guān)鍵控制點(diǎn)的識(shí)別 Ability to specify limits or restrictions for procedural steps in the method方法中各步驟某些限制的特殊規(guī)定 More effective and efficient implementation of the method in the laboratory 在實(shí)驗(yàn)室執(zhí)行方法時(shí)更加有效 Example batch layout 58 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Validation Summary File 方法確認(rèn)總結(jié)文件 Method validation data must be summarized into a report that is clear and easy to 法確認(rèn)數(shù)據(jù)必須總結(jié)為清晰和易于執(zhí)行的報(bào)告 The summary must include總結(jié)中必須包括 : ? Sample type that was used with as much detail as possible (. tissue type and species)樣品類型，應(yīng)提供盡可能多的信息（如組織類型和種類） ? Statement of LOD, LOQ, Precision, Accuracy linearity對(duì)檢出限、定量限、精密度、準(zhǔn)確度和線性范圍的陳述 59 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Verification of Data 數(shù)據(jù)的驗(yàn)證 Performed by QA 由 QA完成 Confirm a sampling of calculations (square root of total number。 1 1Wilson, . “The Performance Characteristics of Analytical MethodsI” (1970) Talanta 17, 2129 5 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 What is Method Validation 何謂方法確認(rèn) ? Validation is the process of determining the suitability of methodology for providing useful analytical 能夠提供有效分析數(shù)據(jù)的過(guò)程。 double sample size if errors are found)從計(jì)算中抽取部分計(jì)算確證（總量的平方根，若發(fā)現(xiàn)錯(cuò)誤，樣品量加倍） Inspect peak integration檢查峰的積分 Confirm sequence integrity確定順序的完整性 60 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Method SOP 方法標(biāo)準(zhǔn)操作程序 Once the validation data has been verified, a method SOP must be written for the procedure.一旦確認(rèn)數(shù)據(jù)通過(guò)驗(yàn)證，實(shí)驗(yàn)過(guò)程必須寫成方法標(biāo)準(zhǔn)操作程序 Include the validation data in the SOP, and specify acceptable ranges for precision and accuracy based on this data (must be at least as good as the reference method)方法標(biāo)準(zhǔn)操作程序中包括確認(rèn)數(shù)據(jù)，根據(jù)以上數(shù)據(jù)，規(guī)定在一可接受范圍內(nèi)的準(zhǔn)確度和精密度（必須至少要與參考方法相當(dāng)） 61 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Method Validation – Summary 方法確認(rèn) 總結(jié) Nonstandard methods must be validated in order to ply with ISO 17025非標(biāo)方法必須經(jīng)過(guò)確認(rèn)以符合 ISO 17025 Validation involves determination of several parameters, including LOD, LOQ, accuracy and precision方法確認(rèn)須測(cè)定若干參數(shù)包括 LOD、 LOQ、準(zhǔn)確度和精密度 Validation data must be summarized into a report and verified by QA確認(rèn)用數(shù)據(jù)必須編寫成報(bào)告并經(jīng) QA部門核查 Once verified, a method SOP must be writte驗(yàn)證后，必須寫成方法標(biāo)準(zhǔn)操作程序 。Method Validation 方法確認(rèn) 2 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Method Validation Objectives方法確認(rèn) – 目標(biāo) By the end of this session you will be able to通過(guò)學(xué)習(xí)你將能夠 : ? Evaluate a new method with respect to what type of validation data are required獲取相關(guān)確認(rèn)數(shù)據(jù)，對(duì)新方法進(jìn)行評(píng)估 ? Assess validation data to determine specific requirements that must be met for the validation to be verified and accepted評(píng)價(jià)確認(rèn)數(shù)據(jù)，以確定方法確認(rèn)應(yīng)滿足的特定要求已經(jīng)驗(yàn)證并可接受 3 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Presentation Outline報(bào)告講述要點(diǎn) Definitions and ISO 17025 requirements相關(guān)定義及 ISO 17025 要求 Validation process方法確認(rèn)過(guò)程 Examples of validation procedures方法確認(rèn)舉例 Parameters to be calculated參數(shù)計(jì)算 ? LOD, LOQ, precision, accuracy, uncertainty檢出限定量限 , 精密度 , 準(zhǔn)確度 , 不確定度 QA verification of data數(shù)據(jù)驗(yàn)證的質(zhì)量保證 4 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 What is a Method何謂方法 ? An analytical method is to be regarded as the set of written instructions pletely describing the procedure to be adopted by the analyst in order to obtain the required analytical ,完整描述分析人員為獲得所需要的分析結(jié)果所采用