過程確認培訓(xùn)

1、過程確認培訓(xùn)過程確認培訓(xùn) Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics 過程確認就是建立一套能證明特定的過程可以以高度的信心持續(xù)地生產(chǎn)出滿足預(yù)定規(guī)格和質(zhì)量特性的產(chǎn)品的書面證據(jù)。 Guidelin

2、es on General Principle of Process 過程確認總原則指導(dǎo)，GMP手冊 Objective evidence is information that can be proved true, based on facts through observation, measurement, test or other means.客觀證據(jù)是可以通過觀察、測量、測試或其他方法被證實為真實的信息。 ISO 8402 2.19 As the old saying goes, “If you didnt document it, you didnt do it!” 正如老話所

3、說“如果你沒有做記錄，就等于你什么也沒做”。 Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.通過檢查并提供客觀證據(jù)來證實已經(jīng)滿足特定的要求。 820.3 (aa)Verification驗證驗證Process Validation Protocol過程確認方案 A document stating how validation will be conducted, including test parameters,

4、product characteristics, manufacturing equipment, and decision points on what constitutes acceptable test results. 說明如何實施確認的文件，包含了測試參數(shù)、產(chǎn)品特性、生產(chǎn)設(shè)備和由什么構(gòu)成可接受測試結(jié)果的判斷要點。 2004 GHTFEstablishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to th

5、e manufacturers approved specification and that the recommendations of the supplier of the equipment are suitably considered.用客觀證據(jù)來支持證明，所安裝的過程設(shè)備和輔助系統(tǒng)的關(guān)鍵安裝方面，能滿足制造商已批準(zhǔn)的技術(shù)規(guī)范，且供應(yīng)商的建議也被恰當(dāng)?shù)目紤]了。Installation qualification (IQ)安裝鑒定（IQ） Operational qualification (OQ)操作鑒定（OQ）Establishing by objective evidence

6、 process control limits and action levels which result in product that meets all predetermined requirements 用客觀證據(jù)確定能夠生產(chǎn)出滿足所有預(yù)定要求的產(chǎn)品的過程控制極限和行動標(biāo)準(zhǔn)。 Performance qualification (PQ)性能鑒定（PQ）establishing by objective evidence that the process, under anticipated conditions, consistently produces a product wh

7、ich meets all predetermined requirements.用客觀證據(jù)確定，在預(yù)期條件下，過程能連續(xù)地產(chǎn)出符合所有預(yù)定要求的產(chǎn)品。 Protocol development方案編制 Process validation protocols should include the following elements:過程確認方案應(yīng)該包括如下元素：l定義過程名稱及確認范圍l定義過程確認前項（人機料法環(huán)等因素）l過程確認的實施計劃l過程確認小組成員及資質(zhì)l安裝鑒定（包括鑒定品名鑒定項目及鑒定參考標(biāo)準(zhǔn)）l操作鑒定（確定作業(yè)員資質(zhì)、作業(yè)方法及參考標(biāo)準(zhǔn)）l性能鑒定（驗證過程及鑒定參考

8、標(biāo)準(zhǔn)）l文件輸出要求l確定目標(biāo)l結(jié)論l有效期及再確認時間 參考過程確認方案模板mportant considerations are:重要的考慮點：確定鑒定項目確定鑒定項目確定操作鑒定標(biāo)準(zhǔn)確定操作鑒定標(biāo)準(zhǔn)確定檢測參考標(biāo)準(zhǔn)及方法確定檢測參考標(biāo)準(zhǔn)及方法參照標(biāo)準(zhǔn)執(zhí)行操作，對操作過程和產(chǎn)出品進行鑒定參照標(biāo)準(zhǔn)執(zhí)行操作，對操作過程和產(chǎn)出品進行鑒定給出鑒定結(jié)果和結(jié)論給出鑒定結(jié)果和結(jié)論1.設(shè)計或工藝的變更對已經(jīng)確認過的過程特性和產(chǎn)品質(zhì)量產(chǎn)生影響，需要進行再確認；2.已經(jīng)確認過的過程，如果設(shè)備、場地變化等，需要進行再確認；3.經(jīng)過確認的過程，如過程條件沒有變化，產(chǎn)品使用中也沒有發(fā)現(xiàn)確認的過程導(dǎo)致的產(chǎn)品批量失效，那么過程確認有效期為3年，3年后需要進行再確認；4.當(dāng)對以往沒有確認過的過程，已經(jīng)生產(chǎn)一段時期后，并根據(jù)各類歷史數(shù)據(jù)重新判定需要確認時，可以采用回顧性確認；Standardization operation is the first thing。All parameters that are validated must be standardized in