【正文】 中國最大的數據庫下載 Benefits of Method Validation 方法確認的益處 Operational efficiency when method is implemented方法執(zhí)行后的操作效率 Design of QA/QC strategy QA/QC方案設計 Avoid embarrassment and damage to lab’s credibility when the method is implemented避免方法執(zhí)行后造成的對實驗室信譽的不良影響 Allows initial estimation of measurement uncertainty對測量不確定度進行初步評估 13 來自 中國最大的數據庫下載 When is Method Validation Necessary何時需要方法確認 ? 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部確認，不過實驗室必須 : ? Have procedures to demonstrate that the method is performing in the particular laboratory environment有程序證明在特定實驗室環(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保留有關文件證明所采用的方法在實驗室可行 . ? 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（例如定購更新服務，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驗證 14 來自 中國最大的數據庫下載 When is Method Validation Necessary何時需要方法確認 ? Laboratorydeveloped (“inhouse”) methods and modified official methods must be validated in order to ply with ISO 17025實驗室內部制定的方法和改進的官方方法必須經過確認 ,以符合 ISO 17025 15 來自 中國最大的數據庫下載 The Validation Process 方法確認過程 What degree of validation is required確認的程度 ? Depends on several factors, including由幾項因素決定，包括 : customer needs顧客需求 intended use of the data數據的用途 type of sample樣品類型 regulatory requirements and法規(guī)要求 whether a standard reference method is available for parison是否標準參考方法能夠進行對比 16 來自 中國最大的數據庫下載 The Validation Process 方法確認過程 ? Careful planning of the validation process is essential方法確認過程需認真設計，這很關鍵 : Often one set of analyses can be used to determine several parameters常常一組分析可測定幾個參數 . Need to ensure that all required parameters can be calculated from the data generated需確保所有所需的參數能夠通過獲得的數據計算出來 . 17 來自 中國最大的數據庫下載 Selecting an Appropriate Method 選擇一個合適的方法 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分析對象的濃度范圍 ? May not be known可能不知道 18 來自 中國最大的數據庫下載 Selecting an Appropriate Method 選擇一個合適的方法 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 中國最大的數據庫下載 Qualitative Needs定性要求 Are analytes predictable分析對象可預見嗎 ? Is concentration predictable濃度可預見嗎 ? Is matrix position predictable基體成分可預見嗎 ? Are matrix blanks available and representative基體空白可測定 ?具有代表性嗎 ? 20 來自 中國最大的數據庫下載 Quantitative Needs定量要求 Different needs for different applications不同應用的不同需求 : ? Conformity to upper and lower certified limits最高和最低限的確認 Formulation or product assay公式表達或產物鑒定 High precision, unbiased高精度，無偏差 21 來自 中國最大的數據庫下載 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、降解產物 ,法規(guī)中規(guī)定的化學品 High precision, unbiased at threshold在極限水平上的高精度、無偏差 22 來自 中國最大的數據庫下載 Quantitative Needs定量要求 ? Chemical behavior studies化學行為研究 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痕量測定 Adequate detection and quantitation levels適當的定性定量水平 23 來自 中國最大的數據庫下載 Preparing for a Method Validation Study 方法確認研究的準備 Necessary to consider the following須考慮 : ? Type of samples to be used to test the performance characteristics of the method測試方法性能特性所用樣品類型 : Reference standards參考標準 CRMs (Certified Reference Materials)有證參考物質 Matrix blanks基體空白 Positives (appropriate matrices)陽性樣品（匹配基體） Other types of control samples其它類型控制樣品 24 來自 中國最大的數