methodvalidation方法確認(rèn)(已修改)
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【正文】 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(mǎn)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)果所采用程序。 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。 2 2 Taylor, . “Validation of Analytical Methods” (1983) Anal. Chem. 55, 600A608A 6 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 ISO 17025: Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are 法確認(rèn)是通過(guò)檢查和提供客觀證據(jù)確證某一特定用途的特殊要求已得到滿(mǎn)足 3 3 ISO 17025 Standard, element 7 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Objective of Method Validation 方法確認(rèn)的目標(biāo) 應(yīng)具有 合理設(shè)計(jì)的 , 充分研究的 , 形成完整文件的 分析方法 能為 既定領(lǐng)域 提供 有用的數(shù)據(jù) To have properly designed, adequately studied, well documented analytical methods capable of producing useful data for the intended application 8 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Sequence of Events 方法確認(rèn)工作的順序 : The process is not necessarily linear – it may be necessary to cycle back through method development at least once before the method can be successfully validated. 方法確認(rèn)不一定是直線進(jìn)程 – 它可能需要隨著方法的開(kāi)發(fā)至少重復(fù)一次直到方法成功確認(rèn) . Method Development 方法改進(jìn) Method Validation 方法確認(rèn) Method Implementation 方法執(zhí)行 9 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 General Classification of Method Validation Studies方法確認(rèn)的分類(lèi) Interlaboratory (between laboratories)實(shí)驗(yàn)室間 ? At least two independent laboratories involved至少兩個(gè)獨(dú)立實(shí)驗(yàn)室 ? Sponsored by professional anizations (AOAC, ASTM)由專(zhuān)業(yè)組織承辦 ? AOAC Official Methods官方方法 – at least 8 labs至少8個(gè)實(shí)驗(yàn)室 ? AOAC Peer Verified Methods同行驗(yàn)證方法 – at least 2 labs至少 2個(gè)實(shí)驗(yàn)室 Intralaboratory (within a laboratory)實(shí)驗(yàn)室內(nèi) 10 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Benefits of Method Validation 方法確認(rèn)的益處 Assessment and optimization of method performance方法性能的評(píng)價(jià)和優(yōu)化 Generation of baseline data for parison to longterm QC data生成基準(zhǔn)數(shù)據(jù)與長(zhǎng)期的質(zhì)控?cái)?shù)據(jù)進(jìn)行比較 Identification of instruments, other equipment, supplies and chemicals required識(shí)別分析儀器、其它設(shè)備、耗材和化學(xué)品的需求 ? Assessment of purchasing needs, cost and potential suppliers評(píng)價(jià)購(gòu)買(mǎi)需求、價(jià)格和可能的供應(yīng)商 11 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Benefits of Method Validation 方法確認(rèn)的益處 Identification of personnel needs個(gè)人需求的識(shí)別 ? Expertise and training專(zhuān)業(yè)技能和培訓(xùn) Consideration of safety and hazardous waste disposal issues對(duì)實(shí)驗(yàn)安全和有害廢物處理的考慮 Demonstration of the laboratory’s ability to meet the requirements of the customer實(shí)驗(yàn)室對(duì)消費(fèi)者需求的滿(mǎn)足能力的展示 12 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Benefits of Method Validation 方法確認(rèn)的益處 Operational efficiency when method is implemented方法執(zhí)行后的操作效率 Design of QA/QC strategy QA/QC方案設(shè)計(jì) Avoid embarrassment and damage to lab’s credibility when the method is implemented避免方法執(zhí)行后造成的對(duì)實(shí)驗(yàn)室信譽(yù)的不良影響 Allows initial estimation of measurement uncertainty對(duì)測(cè)量不確定度進(jìn)行初步評(píng)估 13 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 When is Method Validation Necessary何時(shí)需要方法確認(rèn) ? Official methods (eg. USP, AOAC, Health Canada Compendium, etc.) do not require full internal validation, however the laboratory must官方方法不需要完整內(nèi)部確認(rèn)，不過(guò)實(shí)驗(yàn)室必須 : ? Have procedures to demonstrate that the method is performin
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