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1、2023/7/6,供应商审计,1,药品生产厂对原料供应商的审计Pharmaceutical production plant audits to the raw material suppliers,从源头开始，对产品质量的保证Product quality assurance starting from the source,2023/7/6,供应商审计,2,物料的分类Material classification,物料的分类：原料、辅料、包装材料。Classification:raw material,excipient,packaging material原料+辅料：起始物料，raw m
2、aterial+excipient:starting material原料：有活性的物料，API，raw material:API关键物料：对产品质量有关键影响的物料，在原料、辅料、包装材料中都有关键物料，如何决定是否关键物料，需要我们科学合理的评估。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 ne
3、ed a scientific and rational assessment.,2023/7/6,供应商审计,3,供应商审计的必要性和重要性The necessity and importance of supplier audits,法律法规的要求：必要性，The requirements from the law and regulations issued by government中国GMP的要求：第76条的要求，质量管理部门应会同有关部门对主要物料供应商质量体系进行评估，Chinese GMP,ITEM 76:Quality department has the responsib
4、ility to perform the audit to asses the quality system of the main vendor with related departmentsWHO GMP第8.8条：质量管理负责人有义务协同其他部门批准能提供符合要求的起始原料和包装材料的供应商，WHO GMP item 8.8:Quality management have the responsibility with related departments to approve the manufacturers,they has the ability supply qualifi
5、ed starting materials and packaging materials,WHO GMP第8.9条：对供应商的评估特别要重视供应商的历史和所供应物料的性质，在审计时，首先要确定供应商符合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.,2023/7/6,供应商审计,4,供应商审计的
6、必要性和重要性 The necessity and importance of supplier audits,药品质量是对社会的一种责任：必要性，Drug quality is a responsibility to society:necessity 药品是用来治病救人的，The drugs are used to save lives药品是为了延长人类的生命，Drugs is to prolong human life,药品是为了提高人类的生活质量，The drugs are designed to improve the quality of human life,药品生产企业必须对病
7、人负责，Drug manufacturers must be responsible for the patient,药品生产企业必须对病人的家人和朋友负责，Drug manufacturers must be responsible for the patients family and friends,2023/7/6,供应商审计,5,供应商审计的必要性和重要性 The necessity and importance of supplier audits,药品内在质量很大程度上取决于原辅料和包装材料的质量：重要性，Drug quality depends largely on the q
8、uality of raw materials and packaging materials:importance,药品，制剂产品是由原辅料和包装材料组成的，Drugs,dosage form drug product is composed of the original materials and packaging materials,制剂生产常常只是使用这些原辅料和包装材料，而不对它们进行提纯、精制或预处理，Dosage drug production are often only use these raw materials and packaging materials,and
9、 without refining or pretreatment所以，很大程度上，制剂的质量取决于原辅料和包装材料的内在质量，Drug quality depends largely on the quality of raw materials and packaging materials:importance,近几年来，由于对供应商审计的忽视，已经出现了问题，甚至药害事件，张则敬文件夹PPT培训资料GMP与药品生产-药害事件举例.ppt In recent years,due to the neglect of the audit of the supplier,there have
10、been a problem,or even injury event,2023/7/6,供应商审计,6,供应商审计的职责department responsible to the vendor audit,供应商审计与以下部门密切有关：the vendor audit is related to following departments:生产部门：是使用物料的部门，物料质量有问题，不能生产出优质的产品，production:is using material,and will not produce quality product with problem materials采购部门：物料
11、进厂的第一道把关，应该严格按照质量标准进行采购，purchase:is the first door to control,and should purchase material based on pre-approved specifications,QC部门：对进厂物料严格把关的部门，QC:performs test and control,QA部门：牵头对供应商进行审计和作出决定的部门，当然以上部门都应该参与对供应商的审计，QA:involves vendor audit and makes decision.,2023/7/6,供应商审计,7,如何对供应商进行审计How the au
12、dit conduct,书面程序必须形成，并得到质量部门领导的批准，Need SOP,that has been approved by QA.书面程序的内容：SOP should have following contents:目的、范围、责任者，purpose,scope,responsibilities,物料和受审供应商的清单，及其他们的分类，materials list,suppliers list.审计的频率、方式和可接受的供应商标准，audit frequency,acceptable specifications,审计的内容、记录和评估报告，audit contents,reco
13、rds and evaluation report,供应商的批准和再审计，vendor approving,re-audit,合格供应商名录和档案的管理，等。Approved vendor list and file management,2023/7/6,供应商审计,8,物料的分类关键供应商material classification-key supplier,API：所有的API都是关键供应商，必须定期审计，而且是现场审计，API:all API are key suppliers,should be periodically audited in site,辅料：对每一种辅料分别进行评
14、估，按照它们的重要程度决定是否关键供应商，如果属于关键供应商，必须定期现场审计，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,包装材料：直接接触药品的包装材料，就是关键包装材料，必须定期进行现场审计，Packaging materials:packagin
15、g materials direct contact with drug,is the key packaging materials,on-site audit must be conducted regularly,2023/7/6,供应商审计,9,一般供应商general supplier,除了上面所讲的供应商，其他的就是一般供应商，对他们的审计可以采用以下方式：In addition to the above stated vendor,the other is the general supplier,the audit can be used in the following wa
16、ys:定期现场审计，间隔的时间可以相对长一些，Periodic on-site audit,the time interval can be relatively longer,定期的书面审计，或者问卷的形式，请供应商及时填写并反馈，Regular written audit,or in the form of the questionnaire,the suppliers to timely complete and feedback,2023/7/6,供应商审计,10,供应商审计的频率 audit frequency,关键供应商：现场审计，每两年一次，key vendor:in site
17、audit,once each two years,非关键供应商：每两年一次书面审计，配合 3-4年现场审计一次，no-key vendor:written audit once each two years and in site audit,once each 3-4 years,一般供应商书面审计：每两年一次书面审计，general vendor written audit:written audit once each two years,2023/7/6,供应商审计,11,供应商审计的内容 audit contents,现场审计或书面审计前，应该请供应商准备好的资料：before i
18、n site audit and written audit,the vendor should be requested to prepare followingmaterials:供应商（最好是生产商）的资质证明文件，Suppliers(preferably manufacturers)qualification documents,所供应物料的质量标准，Supply the material quality standards,组织结构图，Organizational chart,质量部门的书面职责，等，Quality department in writing duties.,2023
19、/7/6,供应商审计,12,供应商审计的内容 audit contents,书面审计的内容：written audit 应该在有关的SOP中附有书面审计或问卷的样张,The relevant SOPs should be accompanied by proof of a written audit or questionnaire,内容应该涉及有关产品的质量和质量管理的内容，The content should relate to the product quality and quality management 至少包括：物料管理、生产管理、人员健康和培训管理、设备仪器管理、化验室管理和
20、质量管理等方面，At least include:materials management,production management,personnel health and training management,equipment and instument management,laboratory management and quality management,2023/7/6,供应商审计,13,供应商审计的内容 audit contents,现场审计的内容：in site audit现场检查：至少包括仓库、仪器校验和生产现场、化验室，检查时，可以按照检查表列出来的内容进行并记录
21、，记录应该详尽，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 查阅文件：批记录、批分析记录、原辅料分析记录、计量器具校验记录、环境监控记录、人员培训记录，人员体检记录和相关的SOP等，查阅的同时，进行
22、详细的记录，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,2023/7/6,供应商审计,
23、14,供应商审计的评估和报告The vendor evaluation and audit report,对现场审计的情况进行评估，On-site audit to assess评估的标准：按照SOP中的规定评估，Assessment criteria:assessment,in accordance with the provisions of the SOP得出结论,可以采取打分的方法，将得分与标准进行比较，得出是否合格的结论，Conclusion:the scoring method can be taken to compare scores with standard eligibi
24、lity conclusion,撰写报告，递交给有关领导审阅和批准，Written report then submitted to relevant leaders for review and approval,不管需要供应商进行整改的，或有其他要求，或没有问题的，都要向供应商发出书面的审计报告，并要求及时反馈，可以在收到反馈后再行批准，Regardless of the supplier for rectification of,or other requirements,or that there is no problem,a written audit report should
25、be sent to the supplier,and timely feedback is required.And the approval can be released after receive feedback.,2023/7/6,供应商审计,15,合格供应商的名录 Approved vendor list,供应商经过批准，就成为了合格供应商，该信息应该及时通知有关部门，The vendor has been approved,and become an approved vendor,the information should be informed to related de
26、partments in timely manner,供应商审计SOP应该明确：各责任部门应该做什么事情，包括合格供应商名录的发放，Supplier audit SOP should be clear:the responsible departments should do something,including the issuance of the list of qualified suppliers,合格供应商名录应该及时更新，List of qualified suppliers should be updated合格供应商名录应该发到各个使用的部门，比如：采购部门、仓库、取样人员
27、、化验室人员和生产部门等，List of qualified suppliers should be sent to the various use sectors,such as:purchasing department,warehouse,sampling personnel,laboratory personnel and production departments,2023/7/6,供应商审计,16,供应商的变更或者增加Suppliers to change or add,需要供应商变更文件的规定，也可以列入变更的管理中，need an SOP for changing suppl
28、ier,or included in change control SOP,规定供应商变更需要办的手续，填写的表格，准备的资料等各种要求，state the requirements,formalities,the form to be filled out,prepare the information,requirements根据需要，安排不同的审计，验证等工作，based on the requirement,arrange audits and validation,报告，report,批准，approve,2023/7/6,供应商审计,17,供应商审计 vendor audit,审计
29、供应商的质量管理体系是否有效地工作，Audit supplier quality management system to work effectively,评估供应商各分体系是否处于受控状态，Evaluating vendor sub-system in a controlled state,评估供应商是否能持久地提供优质的物料，Assessment whether the supplier can be sustained to provide quality materials,评估供应商是否能不断的自我完善，Assess whether the supplier can continu
30、e to self-improvement,以上各点都是为了保证我们自己的产品质量，The above points are in order to ensure the quality of our own products,所以产品质量的保证需要供应商的共同参与和保证，Therefore,product quality assurance requires suppliers to participate in and guarantee产品质量的管理必须从源头抓起，Management of product quality from the source,产品质量是我们和供应商共同的责任。The product quality is the common responsibility of our suppliers and ourselves.,
