藥品生產(chǎn)企業(yè)gmp驗(yàn)證培訓(xùn)巴斯德2管理機(jī)構(gòu)對(duì)制藥企業(yè)檢查展望(編輯修改稿)
2025-06-22 18:20 本頁(yè)面
【文章內(nèi)容簡(jiǎn)介】 visions, authorised products 有關(guān)許可證事宜：所持許可證，生產(chǎn)基地，授權(quán)員工，特殊產(chǎn)品帶來(lái)的局限性 2022/6/23 13 Preparation for Inspection檢查的準(zhǔn)備工作 ? Agree the time of the post inspection meeting同意檢查后會(huì)議的時(shí)間 ? Describe its purpose目的描述 ? Summarize the way the deficiencies are to be classified 概述缺陷的分類方式 ? Indicate any documentation required指出所需的任何文件 ? Review Management structure審核管理框架 2022/6/23 14 Preparation for Inspection檢查的準(zhǔn)備工作 ? Review the Company’s Quality Policy and arrangements for monitoring the quality system 審核公司質(zhì)量政策及質(zhì)量系統(tǒng)監(jiān)控的安排 ? Review Changes審核變更情況 ? Review progress with deficiencies審核缺陷的跟進(jìn)工作 2022/6/23 15 OnSite Inspection現(xiàn)場(chǎng)檢查 ? Walk through the Site走一遍廠區(qū) ? Inspect to determine the degree of conformity of the operations to the requirements of GMP and pliance with the licence and details in the application 檢查確定實(shí)際運(yùn)作與 GMP要求的符合程度及實(shí)際運(yùn)用與許可證要求的一致性 ? Itinerary determined by the type of inspection確定檢查路線 2022/6/23 16 OnSite Inspection現(xiàn)場(chǎng)檢查 ? The inspection should follow a logical sequence檢查應(yīng)按一定的邏輯順序 ? Observations, remendations and deficiencies should be discussed with the pany representatives at the time 發(fā)現(xiàn)的不到之處，建議和缺陷應(yīng)與及時(shí)與廠房代表溝通 ? It is important to mention 171。 plus 187。 points提及《附加》項(xiàng)這點(diǎn)很重要 ? Follow the plan as far as possible盡可能多地按計(jì)劃進(jìn)行 ? The inspection is based on Observations 檢查要基于 觀察 2022/6/23 17 OnSite Inspection現(xiàn)場(chǎng)檢查 ? Inspectors may use a check list to ensure all areas of operations are investigated檢查員可以使用檢查表來(lái)確認(rèn)所有區(qū)域均列入 ? Experience has shown that rigid adherence to a very detailed check list developed from GMP Guidelines can lead to missing vulnerable areas經(jīng)驗(yàn)告訴人們嚴(yán)格按照根據(jù) GMP指南上套用下的明細(xì)表來(lái)檢查會(huì)錯(cuò)過(guò)一些簿弱環(huán)節(jié) ? Inspectors should not be concerned with nonGMP aspects eg finance, H amp。 S檢查員不應(yīng)關(guān)心與 GMP無(wú)關(guān)的事宜，例如：財(cái)務(wù)， H amp。 S 2022/6/23 18 OnSite Inspection現(xiàn)場(chǎng)檢查 ? Medicines Testing Scheme : Inspectors samples醫(yī)學(xué)試驗(yàn)計(jì)劃：檢查員樣品 ? During inspections samples of starting materials, work in progress and finished product can be taken for testing if the Inspector considers that it might assist in the detection of quality deficiencies 檢查過(guò)程中，如果檢查員認(rèn)為可能對(duì)判斷質(zhì)量缺陷有幫助，則應(yīng)取原材料樣品、過(guò)程中樣及成品來(lái)做試驗(yàn) ? Documentation Review文件審核 An essential part of the ? This is
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