gmp供應(yīng)商審計ppt課件(參考版)
2025-05-08 12:15本頁面
【正文】 The product quality is the mon responsibility of our suppliers and ourselves. 。s family and friends, 2022/6/2 供應(yīng)商審計 5 供應(yīng)商審計的必要性和重要性 The necessity and importance of supplier audits ? 藥品內(nèi)在質(zhì)量很大程度上取決于原輔料和包裝材料的質(zhì)量：重要性， Drug quality depends largely on the quality of raw materials and packaging materials: importance, – 藥品，制劑產(chǎn)品是由原輔料和包裝材料組成的， Drugs, dosage form drug product is posed of the original materials and packaging materials, – 制劑生產(chǎn)常常只是使用這些原輔料和包裝材料，而不對它們進行提純、精制或預(yù)處理， Dosage drug production are often only use these raw materials and packaging materials, and without refining or pretreatment – 所以，很大程度上，制劑的質(zhì)量取決于原輔料和包裝材料的內(nèi)在質(zhì)量，Drug quality depends largely on the quality of raw materials and packaging materials: importance, – 近幾年來，由于對供應(yīng)商審計的忽視，已經(jīng)出現(xiàn)了問題，甚至藥害事件，張則敬文件夾 \PPT培訓(xùn)資料 \GMP與藥品生產(chǎn) 藥害事件舉例 .ppt In recent years, due to the neglect of the audit of the supplier, there have been a problem, or even injury event 2022/6/2 供應(yīng)商審計 6 供應(yīng)商審計的職責(zé) department responsible to the vendor audit ? 供應(yīng)商審計與以下部門密切有關(guān)： the vendor audit is related to following departments: – 生產(chǎn)部門：是使用物料的部門，物料質(zhì)量有問題，不能生產(chǎn)出優(yōu)質(zhì)的產(chǎn)品， production: is using material, and will not produce quality product with problem materials – 采購部門：物料進廠的第一道把關(guān)，應(yīng)該嚴(yán)格按照質(zhì)量標(biāo)準(zhǔn)進行采購， purchase: is the first door to control, and should purchase material based on preapproved specifications, – QC部門：對進廠物料嚴(yán)格把關(guān)的部門， QC: performs test and control, – QA部門：牽頭對供應(yīng)商進行審計和作出決定的部門，當(dāng)然以上部門都應(yīng)該參與對供應(yīng)商的審計， QA: involves vendor audit and makes decision. 2022/6/2 供應(yīng)商審計 7 如何對供應(yīng)商進行審計 How the audit conduct ? 書面程序必須形成，并得到質(zhì)量部門領(lǐng)導(dǎo)的批準(zhǔn)， Need SOP, that has been approved by QA. ? 書面程序的內(nèi)容： SOP should have following contents: – 目的、范圍、責(zé)任者， purpose, scope, responsibilities, – 物料和受審供應(yīng)商的清單，及其他們的分類， materials list, suppliers list. – 審計的頻率、方式和可接受的供應(yīng)商標(biāo)準(zhǔn)， audit frequency, acceptable specifications, – 審計的內(nèi)容、記錄和評估報告， audit contents, records and evaluation report, – 供應(yīng)商的批準(zhǔn)和再審計， vendor approving, re
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