過(guò)程確認(rèn)培訓(xùn)

1、過(guò)程確認(rèn)培訓(xùn)過(guò)程確認(rèn)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(guò)程確認(rèn)就是建立一套能證明特定的過(guò)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(guò)程確認(rèn)總原則指導(dǎo)，GMP手冊(cè) 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(guò)觀察、測(cè)量、測(cè)試或其他方法被證實(shí)為真實(shí)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(shuō)“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(guò)檢查并提供客觀證據(jù)來(lái)證實(shí)已經(jīng)滿足特定的要求。 820.3 (aa)Verification驗(yàn)證驗(yàn)證Process Validation Protocol過(guò)程確認(rèn)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(shuō)明如何實(shí)施確認(rèn)的文件，包含了測(cè)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(cè)試結(jié)果的判斷要點(diǎn)。 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(lái)支持證明，所安裝的過(guò)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(guò)程控制極限和行動(dòng)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(guò)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(guò)程確認(rèn)方案應(yīng)該包括如下元素：l定義過(guò)程名稱及確認(rèn)范圍l定義過(guò)程確認(rèn)前項(xiàng)（人機(jī)料法環(huán)等因素）l過(guò)程確認(rèn)的實(shí)施計(jì)劃l過(guò)程確認(rèn)小組成員及資質(zhì)l安裝鑒定（包括鑒定品名鑒定項(xiàng)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(yàn)證過(guò)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(rèn)時(shí)間 參考過(guò)程確認(rèn)方案模板mportant considerations are:重要的考慮點(diǎn)：確定鑒定項(xiàng)目確定鑒定項(xiàng)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(cè)參考標(biāo)準(zhǔn)及方法確定檢測(cè)參考標(biāo)準(zhǔn)及方法參照標(biāo)準(zhǔn)執(zhí)行操作，對(duì)操作過(guò)程和產(chǎn)出品進(jìn)行鑒定參照標(biāo)準(zhǔn)執(zhí)行操作，對(duì)操作過(guò)程和產(chǎn)出品進(jìn)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(jì)或工藝的變更對(duì)已經(jīng)確認(rèn)過(guò)的過(guò)程特性和產(chǎn)品質(zhì)量產(chǎn)生影響，需要進(jìn)行再確認(rèn)；2.已經(jīng)確認(rèn)過(guò)的過(guò)程，如果設(shè)備、場(chǎng)地變化等，需要進(jìn)行再確認(rèn)；3.經(jīng)過(guò)確認(rèn)的過(guò)程，如過(guò)程條件沒有變化，產(chǎn)品使用中也沒有發(fā)現(xiàn)確認(rèn)的過(guò)程導(dǎo)致的產(chǎn)品批量失效，那么過(guò)程確認(rèn)有效期為3年，3年后需要進(jìn)行再確認(rèn)；4.當(dāng)對(duì)以往沒有確認(rèn)過(guò)的過(guò)程，已經(jīng)生產(chǎn)一段時(shí)期后，并根據(jù)各類歷史數(shù)據(jù)重新判定需要確認(rèn)時(shí)，可以采用回顧性確認(rèn)；Standardization operation is the first thing。All parameters that are validated must be standardized in