methodvalidation方法確認(rèn)(編輯修改稿)
2025-07-05 16:05 本頁(yè)面
【文章內(nèi)容簡(jiǎn)介】 y 方法確認(rèn)研究的準(zhǔn)備 Method Validation SOP方法確證的標(biāo)準(zhǔn)操作程序 ? Available to staff performing 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(zhuān)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。D Chemist responsible for method validation高級(jí)研發(fā)人員負(fù)責(zé)方法確認(rèn) ? Interpretation and assessment of technical literature對(duì)專(zhuān)業(yè)文獻(xiàn)的解釋和評(píng)價(jià) ? Knowledge of QA / ISO requirements QA / ISO 相關(guān)知識(shí) ? Able to critically review the data (unbiased)審查數(shù)據(jù)（無(wú)偏見(jiàn)） 28 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Personnel人員 Laboratory Analyst實(shí)驗(yàn)室分析人員 ? Understand customer requirements知曉顧客要求 ? Understand study design and performance characteristics being investigated理解目前研究的特點(diǎn)和相應(yīng)設(shè)計(jì) ? Appropriate laboratory skills適當(dāng)實(shí)驗(yàn)室技能 Setup, optimization, troubleshooting實(shí)驗(yàn)準(zhǔn)備、優(yōu)化、疑難解決 ? Observant, good documentation skills遵守職責(zé)及規(guī)章制度，做好完備記錄 ? Able to assess data quality能夠評(píng)估數(shù)據(jù)質(zhì)量 29 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Scheduling Considerations 計(jì)劃中的注意事項(xiàng) Anticipate difficulty預(yù)見(jiàn)困難 Be prepared to do troubleshooting準(zhǔn)備解決困難 If problems, modify the method to improve the data 如遇問(wèn)題，改進(jìn)方法提高數(shù)據(jù)質(zhì)量 ? don’t continue to repeat analysis with poor method until sufficient amount of adequate data has been obtained在得到充分的數(shù)據(jù)前 ,不必大量重復(fù)比較差的方法 30 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Validation of Food Analysis Methods 食品分析方法的確認(rèn) Suggest that guidance for validation of a method for food analysis be consistent with the validation strategy used by AOAC 參照 AOAC International使用的確認(rèn)規(guī)則 31 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Validation Procedure – AOAC 確認(rèn)程序 – AOAC AOAC method validation includes determination of包括 : ? Selectivity選擇性 ? Linearity線(xiàn)性 ? limit of detection (LOD) 檢出限 ? limit of quantitation (LOQ)定量限 ? Recovery回收率 ? Precision精密度 ? Accuracy準(zhǔn)確度 32 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Validation Procedure – AOAC 確認(rèn)程序 – AOAC Must provide evidence of必須提供 : ? Analyte identification被分析物的識(shí)別 ? Separation of analyte from interfering substances將被分析物從干擾物質(zhì)中分離 ? Applicability of the method for measuring the analyte in the particular matrix在特殊基體中該法測(cè)定被分析物的能力 Typically, a minimum of 5 analyses must be conducted on different days 特別要注意，最少5個(gè)分析結(jié)果必須在 5個(gè)不同的工作日完成 33 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Selectivity選擇性 Definition定義 : The method responds primarily to the analyte of interest and is little affected by other substances 方法主要對(duì)被分析物響應(yīng)，其它物質(zhì)的影響很小 May be demonstrated using reference standards, blanks, and spikes可用參考標(biāo)準(zhǔn)、空白和加標(biāo)論證 : ? Identification by parison to behavior of reference standard與參考標(biāo)準(zhǔn)的行為比較進(jìn)行識(shí)別 ? Most conclusive if matrix blank is available基體空白更具說(shuō)服力 34 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Selectivity選擇性 Blank空白 : ? Depending on the type of blank, provides different information on sources of interferences and contamination根據(jù)不同類(lèi)型的空白，可給出不同種類(lèi)的干擾和污染的信息 Field blanks場(chǎng)地空白 Trip blanks路途空白 Matrix blanks基體空白 Laboratory reagent blanks實(shí)驗(yàn)室試劑空白 Instrument blanks 儀器空白 … 35 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Selectivity選擇性 For method validation, a variety of blanks should be assessed 在方法確認(rèn)中，需要對(duì)一系列的空白進(jìn)行評(píng)估 ? Identify and control sources of interferences識(shí)別和控制干擾來(lái)源 The purpose of the blanks and the information that will be acquired from analyzing blank data should be well defined and understood空白的目的 和空白數(shù)據(jù)分析信息的意義要實(shí)現(xiàn) 準(zhǔn)確定義和理解 36 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Selectivity選擇性 Qualitatively demonstrating selectivity from blank and spike data從空白和加標(biāo)數(shù)據(jù)定性證明選擇性 : ? Compare the data (blank vs. spike)數(shù)據(jù)比對(duì)（空白與加標(biāo)） ? Ideally, no analyte detected in blank理想條件下，空白中不得檢出被測(cè)物 ? If interference present – identify source and eliminate如果干擾存在，找到來(lái)源并去除 If source is sample matrix – modify method to eliminate interference如果來(lái)源于樣品基體 改進(jìn)方法排除干擾 37 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Selectivity選擇性 Supporting qualitative data may be provided by定性分析數(shù)據(jù)的提供 : ? Spectral data (UV, MS, fluorescence, IR, atomic emission, etc.)光譜數(shù)據(jù)（紫外、質(zhì)譜、熒光、紅外、原子發(fā)射，等等） ? Elemental analysis元素分析 38 來(lái)自 中國(guó)最大的數(shù)據(jù)庫(kù)下載 Selectivity選擇性 Alternate methods or techniques for qualitative confirmation定性確證的其它方法或技術(shù) : ? Different chemical separation techniques各種化學(xué)分離技術(shù) ? Different detection techniques各種檢測(cè)技術(shù) ? Different sample
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