《GMP供應(yīng)商審計(jì)》PPT課件.ppt

2019/9/20,供應(yīng)商審計(jì),1,藥品生產(chǎn)廠對(duì)原料供應(yīng)商的審計(jì) Pharmaceutical production plant audits to the raw material suppliers,從源頭開(kāi)始，對(duì)產(chǎn)品質(zhì)量的保證 Product quality assurance starting from the source,2019/9/20,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(duì)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(píng)估。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.,2019/9/20,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(guó)GMP的要求：第76條的要求，質(zhì)量管理部門應(yīng)會(huì)同有關(guān)部門對(duì)主要物料供應(yīng)商質(zhì)量體系進(jìn)行評(píng)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8.8條：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 8.8: 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8.9條：對(duì)供應(yīng)商的評(píng)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(shí)，首先要確定供應(yīng)商符合GMP的能力。 WHO GMP item 8.9: 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.,2019/9/20,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(duì)社會(huì)的一種責(zé)任：必要性， Drug quality is a responsibility to society: necessity 藥品是用來(lái)治病救人的， The drugs are used to save lives 藥品是為了延長(zhǎng)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(duì)病人負(fù)責(zé)，Drug manufacturers must be responsible for the patient, 藥品生產(chǎn)企業(yè)必須對(duì)病人的家人和朋友負(fù)責(zé)，Drug manufacturers must be responsible for the patients family and friends,2019/9/20,供應(yīng)商審計(jì),5,供應(yīng)商審計(jì)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 composed 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(duì)它們進(jìn)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(lái)，由于對(duì)供應(yīng)商審計(jì)的忽視，已經(jīng)出現(xiàn)了問(wèn)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,2019/9/20,供應(yīng)商審計(jì),6,供應(yīng)商審計(jì)的職責(zé) department responsible to the vendor audit,供應(yīng)商審計(jì)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(wèn)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(gòu)部門：物料進(jìn)廠的第一道把關(guān)，應(yīng)該嚴(yán)格按照質(zhì)量標(biāo)準(zhǔn)進(jìn)行采購(gòu)，purchase: is the first door to control, and should purchase material based on pre-approved specifications, QC部門：對(duì)進(jìn)廠物料嚴(yán)格把關(guān)的部門，QC: performs test and control, QA部門：牽頭對(duì)供應(yīng)商進(jìn)行審計(jì)和作出決定的部門，當(dāng)然以上部門都應(yīng)該參與對(duì)供應(yīng)商的審計(jì)，QA: involves vendor audit and makes decision.,2019/9/20,供應(yīng)商審計(jì),7,如何對(duì)供應(yīng)商進(jìn)行審計(jì) How the audit conduct,書(shū)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(shū)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(jì)的頻率、方式和可接受的供應(yīng)商標(biāo)準(zhǔn)，audit frequency, acceptable specifications, 審計(jì)的內(nèi)容、記錄和評(píng)估報(bào)告，audit contents, records and evaluation report, 供應(yīng)商的批準(zhǔn)和再審計(jì)，vendor approving, re-audit, 合格供應(yīng)商名錄和檔案的管理，等。Approved vendor list and file management,2019/9/20,供應(yīng)商審計(jì),8,物料的分類關(guān)鍵供應(yīng)商 material classification-key supplier,API：所有的API都是關(guān)鍵供應(yīng)商，必須定期審計(jì)，而且是現(xiàn)場(chǎng)審計(jì)， API: all API are key suppliers, should be periodically audited in site, 輔料：對(duì)每一種輔料分別進(jìn)行評(píng)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(chǎng)審計(jì)， Excipients: Each excipient should be evaluated according to their degree of importance to decide whether its key supplier, if they are desided to be a key suppliers, regular on-site 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(jìn)行現(xiàn)場(chǎng)審計(jì)，Packaging materials: packaging materials direct contact with drug, is the key packaging materials, on-site audit must be conducted regularly,2019/9/20,供應(yīng)商審計(jì),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(duì)他們的審計(jì)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(chǎng)審計(jì)，間隔的時(shí)間可以相對(duì)長(zhǎng)一些，Periodic on-site audit, the time interval can be relatively longer, 定期的書(shū)面審計(jì)，或者問(wèn)卷的形式，請(qǐng)供應(yīng)商及時(shí)填寫(xiě)并反饋， Regular written audit, or in the form of the questionnaire, the suppliers to timely complete and feedback,2019/9/20,供應(yīng)商審計(jì),10,供應(yīng)商審計(jì)的頻率 audit frequency,關(guān)鍵供應(yīng)商：現(xiàn)場(chǎng)審計(jì)，每?jī)赡暌淮危琸ey vendor: in site audit, once each two years, 非關(guān)鍵供應(yīng)商：每?jī)赡暌淮螘?shū)面審計(jì)，配合 3-4年現(xiàn)場(chǎng)審計(jì)一次，no-key vendor: written audit once each two years and in site audit, once each 3-4 years, 一般供應(yīng)商書(shū)面審計(jì)：每?jī)赡暌淮螘?shū)面審計(jì)， general vendor written audit : written audit once each two years,2019/9/20,供應(yīng)商審計(jì),11,供應(yīng)商審計(jì)的內(nèi)容 audit contents,現(xiàn)場(chǎng)審計(jì)或書(shū)面審計(jì)前，應(yīng)該請(qǐng)供應(yīng)商準(zhǔn)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(biāo)準(zhǔn)，Supply the material quality standards, 組織結(jié)構(gòu)圖，Organizational chart, 質(zhì)量部門的書(shū)面職責(zé)，等，Quality department in writing duties.,2019/9/20,供應(yīng)商審計(jì),12,供應(yīng)商審計(jì)的內(nèi)容 audit contents,書(shū)面審計(jì)的內(nèi)容： written audit 應(yīng)該在有關(guān)的SOP中附有書(shū)面審計(jì)或問(wèn)卷的樣張, The relevant SOPs should be accompanied by proof of a written audit or questionnaire, 內(nèi)容應(yīng)該涉及有關(guān)產(chǎn)品的質(zhì)量和質(zhì)量管理的內(nèi)容，The content should relate to the product quality and quality management 至少包括：物料管理、生產(chǎn)管理、人員健康和培訓(xùn)管理、設(shè)備儀器管理、化驗(yàn)室管理和質(zhì)量管理等方面，At least include: materials management, production management, personnel health and training management, equipment and instument management, laboratory management and quality management,2019/9/20,供應(yīng)商審計(jì),13,供應(yīng)商審計(jì)的內(nèi)容 audit contents,現(xiàn)場(chǎng)審計(jì)的內(nèi)容： in site audit 現(xiàn)場(chǎng)檢查：至少包括倉(cāng)庫(kù)、儀器校驗(yàn)和生產(chǎn)現(xiàn)場(chǎng)、化驗(yàn)室，檢查時(shí)，可以按照檢查表列出來(lái)的內(nèi)容進(jìn)行并記錄，記錄應(yīng)該詳盡，In site inspection: At least, including warehouses, instrument calibration and production sites, laboratories. The inspection should be in accordance with the checklist list of content and records, the records should be detailed 查閱文件：批記錄、批分析記錄、原輔料分析記錄、計(jì)量器具校驗(yàn)記錄、環(huán)境監(jiān)控記錄、人員培訓(xùn)記錄，人員體檢記錄和相關(guān)的SOP等，查閱的同時(shí)，進(jìn)行詳細(xì)的記錄， Access to documents: batch records, analysis records, raw material analysis records, measuring instruments calibration records, environmental monitoring records, personnel training records, personnel and medical records and related SOP, etc., accessible at the same time, detailed records,2019/9/20,供應(yīng)商審計(jì),14,供應(yīng)商審計(jì)的評(píng)估和報(bào)告 The vendor evaluation and audit report,對(duì)現(xiàn)場(chǎng)審計(jì)的情況進(jìn)行評(píng)估，On-site audit to assess 評(píng)估的標(biāo)準(zhǔn)：按照SOP中的規(guī)定評(píng)估，Assessment criteria: assessment, in accordance with the provisions of the SOP 得出結(jié)論,可以采取打分的方法，將得分與標(biāo)準(zhǔn)進(jìn)行比較，得出是否合格的結(jié)論，Conclusion: the scoring method can be taken to compare scores with standard eligibility conclusion, 撰寫(xiě)報(bào)告，遞交給有關(guān)領(lǐng)導(dǎo)審閱和批準(zhǔn)，Written report then submitted to relevant leaders for review and approval, 不管需要供應(yīng)商進(jìn)行整改的，或有其他要求，或沒(méi)有問(wèn)題的，都要向供應(yīng)商發(fā)出書(shū)面的審計(jì)報(bào)告，并要求及時(shí)反饋，可以在收到反饋后再行批準(zhǔn)，Regardless of the supplier for rectification of, or other requirements, or that there is no problem, a written audit report should be sent to the supplier, and timely feedback is required. And the approval can be released after receive feedback.,2019/9/20,供應(yīng)商審計(jì),15,合格供應(yīng)商的名錄 Approved vendor list,供應(yīng)商經(jīng)過(guò)批準(zhǔn)，就成為了合格供應(yīng)商，該信息應(yīng)該及時(shí)通知有關(guān)部門，The vendor has been approved, and become an approved vendor, the information should be informed to related departments in timely manner, 供應(yīng)商審計(jì)SOP應(yīng)該明確：各責(zé)任部門應(yīng)該做什么事情，包括合格供應(yīng)商名錄的發(fā)放，Supplier audit SOP should be clear: the responsible departments should do something, including the issuance of the list of qualified suppliers, 合格供應(yīng)商名錄應(yīng)該及時(shí)更新，List of qualified suppliers should be updated 合格供應(yīng)商名錄應(yīng)該發(fā)到各個(gè)使用的部門，比如：采購(gòu)部門、倉(cāng)庫(kù)、取樣人員、化驗(yàn)室人員和生產(chǎn)部門等，List of qualified suppliers should be sent to the various use sectors, such as: purchasing department, warehouse, sampling personnel, laboratory personnel and production departments,2019/9/20,供應(yīng)商審計(jì),16,供應(yīng)商的變更或者增加Suppliers to change or add,需要供應(yīng)商變更文件的規(guī)定，也可以列入變更的管理中，need an SOP for changing supplier, or included in change control SOP, 規(guī)定供應(yīng)商變更需要辦的手續(xù)，填寫(xiě)的表格，準(zhǔn)備的資料等各種要求，stat