gmp供應(yīng)商審計(jì)ppt課件-文庫吧資料
2025-05-11 12:15本頁面
【正文】 audit, – 合格供應(yīng)商名錄和檔案的管理，等。 Key materials: materials have critical impact on product quality, key material is in the raw materials, auxiliary materials, packaging materials. How to decide key materials, we need a scientific and rational assessment. 2022/6/2 供應(yīng)商審計(jì) 3 供應(yīng)商審計(jì)的必要性和重要性 The necessity and importance of supplier audits ? 法律法規(guī)的要求：必要性， The requirements from the law and regulations issued by government – 中國 GMP的要求：第 76條的要求，質(zhì)量管理部門應(yīng)會同有關(guān)部門對主要物料供應(yīng)商質(zhì)量體系進(jìn)行評估， Chinese GMP, ITEM 76: Quality department has the responsibility to perform the audit to asses the quality system of the main vendor with related departments – WHO GMP第 ：質(zhì)量管理負(fù)責(zé)人有義務(wù)協(xié)同其他部門批準(zhǔn)能提供符合要求的起始原料和包裝材料的供應(yīng)商， WHO GMP item : Quality management have the responsibility with related departments to approve the manufacturers, they has the ability supply qualified starting materials and packaging materials, – WHO GMP第 ：對供應(yīng)商的評估特別要重視供應(yīng)商的歷史和所供應(yīng)物料的性質(zhì)，在審計(jì)時，首先要確定供應(yīng)商符合 GMP的能力。2022/6/2 供應(yīng)商審計(jì) 1 藥品生產(chǎn)廠對原料供應(yīng)商的審計(jì) Pharmaceutical production plant audits to the raw material suppliers 從源頭開始，對產(chǎn)品質(zhì)量的保證 Product quality assurance starting from the source, 2022/6/2 供應(yīng)商審計(jì) 2 物料的分類 Material classification ? 物料的分類：原料、輔料、包裝材料。 Classification: raw material, excipient, packaging material ? 原料 +輔料： 起始物料， raw material + excipient: starting material ? 原料： 有活性的物料， API， raw material: API ? 關(guān)鍵物料：對產(chǎn)品質(zhì)量有關(guān)鍵影響的物料，在原料、輔料、包裝材料中都有關(guān)鍵物料，如何決定是否關(guān)鍵物料，需要我們科學(xué)合理的評估。 WHO GMP item : The assess to vendor should pay attention on the history and material characteristics, and verify the ability of the vendor about they perform the GMP. 2022/6/2 供應(yīng)商審計(jì) 4 供應(yīng)商審計(jì)的必要性和重要性 The necessity and importance of supplier audits ? 藥品質(zhì)量是對社會的一種責(zé)任：必要性， ? Drug quality is a responsibility to society: necessity 藥品是用來治病救人的， The drugs are used to save lives 藥品是為了延長人類的生命， Drugs is to prolong human life, 藥品是為了提高人類的生活質(zhì)量， The drugs are designed to improve the quality of human life, 藥品生產(chǎn)企業(yè)必須對病
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