methodvalidation方法確認(rèn)-文庫(kù)吧
2025-04-26 16:05 本頁(yè)面
【正文】 g in the particular laboratory environment有程序證明在特定實(shí)驗(yàn)室環(huán)境下該方法可行 . ? Retain documented evidence that the method is performing as expected and the lab has accepted the performance保留有關(guān)文件證明所采用的方法在實(shí)驗(yàn)室可行 . ? Ensure that the most current method is available (eg. subscribe to an update service, or use other means to ensure the most current version of the method is available to the analyst).確保有最新有效的方法（例如定購(gòu)更新服務(wù)，或使用其它方法確保分析人員能得到最新有效版的方法） ? VERIFICATION驗(yàn)證 14 來自 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) ? Laboratorydeveloped (“inhouse”) methods and modified official methods must be validated in order to ply with ISO 17025實(shí)驗(yàn)室內(nèi)部制定的方法和改進(jìn)的官方方法必須經(jīng)過確認(rèn) ,以符合 ISO 17025 15 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 The Validation Process 方法確認(rèn)過程 What degree of validation is required確認(rèn)的程度 ? Depends on several factors, including由幾項(xiàng)因素決定，包括 : customer needs顧客需求 intended use of the data數(shù)據(jù)的用途 type of sample樣品類型 regulatory requirements and法規(guī)要求 whether a standard reference method is available for parison是否標(biāo)準(zhǔn)參考方法能夠進(jìn)行對(duì)比 16 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 The Validation Process 方法確認(rèn)過程 ? Careful planning of the validation process is essential方法確認(rèn)過程需認(rèn)真設(shè)計(jì)，這很關(guān)鍵 : Often one set of analyses can be used to determine several parameters常常一組分析可測(cè)定幾個(gè)參數(shù) . Need to ensure that all required parameters can be calculated from the data generated需確保所有所需的參數(shù)能夠通過獲得的數(shù)據(jù)計(jì)算出來 . 17 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Selecting an Appropriate Method 選擇一個(gè)合適的方法 Information required to determine if reference method is appropriate通過各種信息來決定方法是否合適 : ? What are the analytes of interest分析對(duì)象是什么 ? ? What is the sample matrix樣品基體是什么 ? ? What is the concentration range of interest分析對(duì)象的濃度范圍 ? May not be known可能不知道 18 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Selecting an Appropriate Method 選擇一個(gè)合適的方法 Information required需要以下信息 : ? What are the qualitative and quantitative needs定性和定量要求 ? ? What level of detection and quantitation are required檢出限和定量限是多少 ? ? Are the samples / analytes stable樣品或被分析物穩(wěn)定是否穩(wěn)定 ? 19 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Qualitative Needs定性要求 Are analytes predictable分析對(duì)象可預(yù)見嗎 ? Is concentration predictable濃度可預(yù)見嗎 ? Is matrix position predictable基體成分可預(yù)見嗎 ? Are matrix blanks available and representative基體空白可測(cè)定 ?具有代表性嗎 ? 20 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Quantitative Needs定量要求 Different needs for different applications不同應(yīng)用的不同需求 : ? Conformity to upper and lower certified limits最高和最低限的確認(rèn) Formulation or product assay公式表達(dá)或產(chǎn)物鑒定 High precision, unbiased高精度，無偏差 21 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Quantitative Needs定量要求 ? Conformity to tolerance levels or regulatory thresholds與允許量水平或極限量符合性 Contaminants, impurities, degradation products, regulated chemicals污染物、雜質(zhì)、降解產(chǎn)物 ,法規(guī)中規(guī)定的化學(xué)品 High precision, unbiased at threshold在極限水平上的高精度、無偏差 22 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Quantitative Needs定量要求 ? Chemical behavior studies化學(xué)行為研究 Degradation studies, stability studies, environmental fate studies降解、穩(wěn)定性和環(huán)境歸屬研究 Usually requires high sensitivity常需高靈敏度 ? Trace level measurements痕量測(cè)定 Adequate detection and quantitation levels適當(dāng)?shù)亩ㄐ远克? 23 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Preparing for a Method Validation Study 方法確認(rèn)研究的準(zhǔn)備 Necessary to consider the following須考慮 : ? Type of samples to be used to test the performance characteristics of the method測(cè)試方法性能特性所用樣品類型 : Reference standards參考標(biāo)準(zhǔn) CRMs (Certified Reference Materials)有證參考物質(zhì) Matrix blanks基體空白 Positives (appropriate matrices)陽(yáng)性樣品（匹配基體） Other types of control samples其它類型控制樣品 24 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Preparing for a Method Validation Study 方法確認(rèn)研究的準(zhǔn)備 Chemicals and Supplies化學(xué)試劑和耗材 : ? Source(s)來源 ? Cost費(fèi)用 ? Quality質(zhì)量 ? Quantities available可得到的數(shù)量 ? Special handling or storage requirements特殊處理和保管要求 ? ? Special training required for analysts對(duì)分析人員的專門培訓(xùn) ? ? Waste disposal廢物處理 25 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Preparing for a Method Validation Study 方法確認(rèn)研究的準(zhǔn)備 Equipment / Instruments儀器 /設(shè)備 : ? Source(s)來源 ? Cost價(jià)值 ? Space , maintenance and training requirements空間、維護(hù)和培訓(xùn)要求 ? Service and support維修和技術(shù)支持 ? Availability of consumables易耗品 26 來自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Preparing for a Method Validation Stud
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