gmp供應(yīng)商審計ppt課件-wenkub.com
2025-05-02 12:15 本頁面
【正文】 Approved vendor list and file management, 2022/6/2 供應(yīng)商審計 8 物料的分類 —關(guān)鍵供應(yīng)商 material classificationkey supplier ? API：所有的 API都是關(guān)鍵供應(yīng)商，必須定期審計，而且是現(xiàn)場審計， API: all API are key suppliers, should be periodically audited in site, ? 輔料：對每一種輔料分別進行評估，按照它們的重要程度決定是否關(guān)鍵供應(yīng)商，如果屬于關(guān)鍵供應(yīng)商，必須定期現(xiàn)場審計， Excipients: Each excipient should be evaluated according to their degree of importance to decide whether it’ s key supplier, if they are desided to be a key suppliers, regular onsite audit is needed, ? 包裝材料：直接接觸藥品的包裝材料，就是關(guān)鍵包裝材料，必須定期進行現(xiàn)場審計， Packaging materials: packaging materials direct contact with drug, is the key packaging materials, onsite audit must be conducted regularly 2022/6/2 供應(yīng)商審計 9 一般供應(yīng)商 general supplier ? 除了上面所講的供應(yīng)商，其他的就是一般供應(yīng)商，對他們的審計可以采用以下方式： In addition to the above stated vendor, the other is the general supplier, the audit can be used in the following ways: – 定期現(xiàn)場審計，間隔的時間可以相對長一些， Periodic onsite audit, the time interval can be relatively longer, – 定期的書面審計，或者問卷的形式，請供應(yīng)商及時填寫并反饋， Regular written audit, or in the form of the questionnaire, the suppliers to timely plete and feedback 2022/6/2 供應(yīng)商審計 10 供應(yīng)商審計的頻率 audit frequency ? 關(guān)鍵供應(yīng)商：現(xiàn)場審計，每兩年一次， key vendor: in site audit, once each two years, ? 非關(guān)鍵供應(yīng)商：每兩年一次書面審計，配合 34年現(xiàn)場審計一次， nokey vendor: written audit once each two years and in site audit, once each 34 years, ? 一般供應(yīng)商書面審計：每兩年一次書面審計， general vendor written audit : written audit once each two years 2022/6/2 供應(yīng)商審計 11 供應(yīng)商審計的內(nèi)容 audit contents ? 現(xiàn)場審計或書面審計前，應(yīng)該請供應(yīng)商準備好的資料： before in site audit and written audit ,the vendor should be requested to prepare followingmaterials: ? 供應(yīng)商（最好是生產(chǎn)商）的資質(zhì)證明文件， Suppliers (preferably manufacturers) qualification documents, – 所供應(yīng)物料的質(zhì)量標準， Supply the material quality standards, – 組織結(jié)構(gòu)圖， Organizational chart, – 質(zhì)量部門的書面職責(zé)，等， Quality department in writing duties. 2022/6/2 供應(yīng)商審計 12 供應(yīng)商審計的內(nèi)容 audit contents ? 書面審計的內(nèi)容： written audit – 應(yīng)該在有關(guān)的 S
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