供应商审计管理规程

1、1. Purpose目的 异常情况处理：如供应商断货，物料异常等To establish a procedure for evaluation and approval of vendors for procurement of raw materials and packaging materials required for manufacturing and packing of finished products.建立对成品生产所需原辅料以及包装材料供应商的资质进行审查和批准的流程。2. Scope范围 This is applicable for approval of all ve

2、ndors supplying raw materials and packaging materials to the site.适用于厂区所有原辅料以及包装材料供应商的批准3. Responsibility 职责 QA：Materials quality 质量保证部：负责物料的质量控制Purchase Department: materials purchase物料采购部：负责物料的采购QC: materials testing质量控制部：负责物料的检测Production: product manufacturing 生产部：负责物料的试用4. Definition 定义Vendor:

3、Manufacturer / Supplier of Raw materials and Packaging materials.供应商：原辅料以及包装材料的生产厂家或供货商。5. Safety Precaution安全注意事项None无6. Procedure规程6.1 General 通则6.1.1 Approved vendor list (AVL) shall be maintained for Active Pharmaceutical Ingredients (API), excipients and packing materials. This shall be prepare

4、d by QA, and approved by QA Manager as per Annexure VI for raw material (RM) and Annexure VII packaging material (PM) respectively. The Approved Vendor List shall be numbered as AVL/RM/01 for raw material (RM) and AVL/PM/01 for packing material (PM), where 01 indicates the Revision No. starting from

5、 01.批准的供应商列表”（AVL）应包括原料（API），辅料以及包装材料的供应商。该列表由QA人员起草，并由QA经理按附件六对原辅料（RM）和附件七包装材料（PM）供应商进行批准。批准的供应商列表应该按照原辅料和包装材料分别命名为AV/RM/01，AV/PM/01。其中01代表修订的版本号，从01开始。6.2 Whenever there is a need for introducing new vendor, Purchase department shall identify the manufacturer/supplier for the required raw material

6、 or packaging material and inform the QA.如果需要添加新的供应商时，采购部门应当确定原辅料以及包装材料的生产商或供应商，并通知QA经理。6.3 QA manager in co-ordination with Purchase department shall arrange for the following from the vendor:QA经理应和采购部门应安排供应商提供下列资料：6.3.1 Technical data package (for API only) (as per Annexure X).技术资料包（只针对API，附录 X）6.

7、3.2 a) Filled Questionnaire for vendor evaluation of Raw Materials Refer Annexure I , Questionnaire for TSE Refer Annexure II which is as per current regulatory requirement including local and EU guideline. The questionnaire is grouped under the following: General information, organization, personne

8、l & training, building and facilities, equipment, Documentation & records, Material management, Laboratory, Quality management system, Environment, safety & hygiene, warehouse, Production and process controls, packaging & labeling controls and transportation.填写附件一原料供应商评估的调查问卷，附件二TSE调

9、查问卷，该问卷是遵循本地以及欧盟现行法规要求。调查问卷包括以下几大类：基本信息，组织结构，人员培训，厂房设施，仪器设备，文件记录，物料管理，实验室，质量管理体系，环境，安全与卫生，仓库，生产以及工艺控制，包装以及标签的管理和运输。b) Filled Questionnaire for vendor evaluation of Packaging materials Refer Format Annexure III.填写附件三包装材料供应商评估的调查问卷。.The vendor evaluation questionnaires can be sent as a hard copy or so

10、ft copy. If sent as soft copy, the effective date, issue date and issued by detail shall be typed.供应商的调查问卷可以以纸质或电子版本形式发送。如果以电子版本形式发送，文件的生效日期，发放日期等都应当注明。6.3.3 The vendor shall fill the questionnaire and forward to QA manager for evaluation.供应商应当填写调查问卷，并反馈给QA经理以便进行评估。6.3.4 QA manager shall evaluate fi

11、lled questionnaire along with technical data package.QA经理应当根据技术资料包和填写的调查问卷进行评估。6.4 Approval of vendor for API API供应商的批准。6.4.1 The approval and disapproval of API vendor shall be done by auditing the facility.审计完API供应商的工厂后再决定是否批准或不批准。 QA manager shall evaluate the filled questionnaire, if not satisfa

12、ctory, vendor shall be rejected and intimated to purchase department.QA经理应当评估供应商所填写的调查问卷，如果不符合要求，应当取消其资格并通知采购部门。6.4.3 If found satisfactory, shall recommend for facility audit, the Purchase Department shall arrange for the same and communicate to QA manager who shall depute a person/s for conducting

13、 the audit. The auditor/(s) shall inspect the site as per Annexure VIII audit checklist for API and check for compliance of the filled questionnaire as per cGMP requirement.如果供应商符合要求，应当建议对其进行审计，采购部门进行安排并和QA经理进行沟通。QA经理指定人员负责审计工作。审计员应当按照附件八原料检查清单对工厂进行审计，还需要检查所填写的问卷内容是否和现场条件一致，是否符合cGMP的要求。Incase of man

14、ufacturer from overseas, audit may be arranged to be conducted by outsourcing a competent person. The competency of the contracted auditor shall be decided by PL holder/QP. The curriculum vitae of the contracted auditor shall be sent to PL holder/QP for their necessary approval.对于国外的生产厂家，审计工作可以安排一名有

15、资质的人员进行。审计员的资质由产品证书所有者或QP来确定。该人员的履历应发送给PL持有者以及QP进行批准。6.4.4 The auditor/s shall prepare the vendor facility audit report as per Annexure V to indicate the points which are in compliance and also cGMP shortfalls/non-compliance /deficiencies noted during the audit if any and corrective actions agreed,

16、compliance report. The report should also state the GMP standard followed by the vendor. For Ex.: EU-GMP, WHO, ICH, FDA, etc. .审计员应当按照附件五准备供应商工厂的审计报告，打分点应体现出厂房是否符合cGMP要求，如果有，还应注明审计中发现的缺陷或不符合性，以及采取的整改措施和报告。报告还应体现出供应商所遵循的GMP标准，例如：欧盟GMP，WHO，ICH， FDA等。6.4.5 QA manager shall review the above data and if

17、found satisfactory shall approve the vendor.QA经理应当审核以上数据，如果合格就批准其为合格供应商。Note In case of contract givers product, the audit report shall be sent to QP for review. Based on the QPs recommendation, the vendors shall be evaluated.备注：如果是合同加工产品，审计报告还应发送给QP，请其审核。根据QP的建议对供应商进行评估。6.4.6 QA manager shall infor

18、m the approval of new vendor to Stores, QC and Purchase through New Vendor Approval Intimation format: Annexure IV. The Approved vendor list shall be updated once in three months, in the meantime if any new vendor is included the same shall be intimated through New Vendor Approval Intimation format:

19、 Annexure IV.QA经理应当及时将附件四新批准供应商通知的信息下发给仓库，QC和采购部门。批准的供应商列表应当每季度更新一次，同时如果有任何新的供应商被批准，都应当下发附件四新批准供应商通知进行通知。4.7 6.The vendor shall provide Certificate of Analysis for each consignment and TSE/BSE Declaration Certificate once in a year. In case of animal origin material the vendor shall provide TSE/BSE

20、Free Certificate / Declaration along with each consignment supplied.供应商都应当提供每批货物的COA，一年更新一次TSE/BSE证明。若是动物来源的产品，每批货物供应商都应当附上无TES/BSE证明。6.4.8 In case of change in site of manufacture, the vendor shall notify about the change before supplying first consignment from new site.如果生产场地发生了变更，供应商应当在提供新场地生产的第一

21、批货之前，通知相关的变更。Note: This information is sent to the Product License (PL) holders for their necessary approval.备注：该信息应当发送给产品证书所有者进行审核、批准。6.5 Approval of Vendor for Excipients and Packaging Materials 辅料以及包装材料供应商的批准。6.5.1 The approval and disapproval of the excipients and secondary packing material vend

22、or shall be done by sending the questionnaire.辅料以及外包材的供应商可以通过调查问卷来决定是否批准其为合格供应商。6.5.2 QA shall evaluate the filled questionnaire received from the vendor of raw material (excipients) as per Format Annexure I, Annexure II and packaging material as per Format Annexure III.QA应当评价由辅料以及包装材料供应商提交的调查问卷，分别为

23、附件一，附件二和附件三。.6.6 Approval of vendor for primary and printed packing materials 内包材和印刷包装材料供应商的批准6.6.1 The approval and disapproval of primary and printed packing materials vendor shall be done by auditing the facility.通过工厂审计来决定内包材以及印刷材料的供应商是否为合格供应商。6.6.2 QA manager shall evaluate the filled questionna

24、ire, if not satisfactory, vendor shall be rejected and intimated to purchase department.QA经理应当审核对方所提供的调查问卷，如果不符合要求，应当不予通过并及时通知采购部门。6.6.3 If found satisfactory, shall recommend for facility audit, the Purchase Department shall arrange for the same and communicate to QA manager who shall depute a pers

25、on/s for conducting the audit. The auditor/(s) shall inspect the site as per Annexure IX the audit checklist for packing materials and check for compliance of the filled questionnaire as per cGMP requirement.如果评估结果符合要求，QA应当建议进行工厂审计，采购部门进行安排并和QA经理进行沟通。QA经理指定人员负责审计工作。审计员应当按照附件九包材审计检查清单对工厂进行审计，还需要检查所填写

26、的问卷内容是否和现场条件一致，是否符合cGMP的要求。6.6.4 The auditor/s shall prepare the vendor facility audit report as per Annexure V to indicate the points which are in compliance and also cGMP shortfalls/non-compliance /deficiencies noted during the audit if any and corrective actions agreed, compliance report. The rep

27、ort should also state the GMP standard followed by the vendor. 审计员应当按照附件五准备供应商工厂的审计报告，打分点应体现出厂房是否符合cGMP要求，如果有，还应注明审计中发现的缺陷或不符合性，以及采取的整改措施和报告。报告还应体现出供应商所遵循的GMP标准。6.6.5 QA manager shall review the above data and if found satisfactory shall approve the vendor.QA经理应当审核以上数据，如果合格就对供应商进行批准。6.7 Vendor Disco

28、ntinuation: 中断和供应商的合作关系6.7.1 Vendor shall be discontinued based on the criticality of the observations.根据观察结果决定是否继续合作6.7.1.1 Critical 关键6.7.1.1.1If do not comply with Approved Specification / Pharmacopoeial requirement / EDQM requirement. If observed during testing, it shall be handled as per XX-SOP

29、-QA038 Handling of Out of specification (OOS) test results.如果检查过程中发现不符合已批准的标准或药典标准或EDQM标准，该情况按照X-SOP-QA038OOS管理规程进行处理。6.7.1.1.2 Vendor has made change(s) in the process without informing to Yiling which is identified during reaudit or at any occurrence. 再审计过程中或者其他情况下发现，供应商产品工艺发生了变更，但没有通知XX。 Vendor m

30、anufactures the material at a site, which is not approved by Yiling which is identified during reaudit or at any occurrence.再审计过程中或者其他情况下发现，供应商产品在未经我方批准的场地进行生产。 Disapproval as per Product holder recommendations.产品证书所有者提出的取消其供应商资格。6.7.1.2 The vendor shall be communicated immediately for the respectiv

31、e issues. Based on the reply and action taken by the vendor, QA manager shall decide whether to continue or not with the vendor. If decided not to continue with the vendor, the vendor shall be disqualified and removed from the approved vendor list immediately. The same shall be communicated to Produ

32、ct License (PL) holders.发现问题应及时与供应商进行沟通。根据供应商的回复以及所采取的措施，QA经理决定是否继续和其合作。如果决定不再合作，应将该供应商列为资质不符合，并立即从批准的供应商列表中删除。同样，该信息也应和产品证书所有者进行沟通。Note 1: Vendor shall be re-qualified only after the satisfactory facility audit report. 备注1：只有工厂审计报告合格后，供应商才可以重新获得资质；Note 2: In case of contract givers product, prior a

33、pproval from Product License (PL) holder shall be obtained before audit for requalification. 备注2：如果是合同加工项目，对供应商进行资格再审查之前应先获得产品证书所有者的批准。Critical issues shall be closed within 30 working days. In case of overseas vendor, the time could be extended to another 15 working days.关键性问题应该在30个工作日内完成，若涉及到海外的供应

34、商，可再延长15个工作日。6.7.1.3 Major主要的6.7.1.3.1 If audit compliance report of the vendor is not justifiable.如果供应商的审计报告显示和现实不符合；6.7.1.3.2 If corrective action not taken or the corrective action taken also not justifiable. 如果未采取整改措施，或采取的整改措施不恰当；.3 Trend data reveals reoccurrence of Quality problems.(Reoccurren

35、ce Repetitive in three months)数据趋势分析发现质量问题反复发生（反复-3个月内重复发生）；6.7.1.3.4 If extraneous material (like black particles) found in the material.如果在物料中发现了异物（如黑色的颗粒）；6.7.1.3.5 Documents provided for the material by the vendor are not as per agreed norms.供应商提供的物料相关的文件与以前的格式不符；6.7.1.3.6 Vendor frequently fail

36、s to supply the material as per committed scheduled time,供应商经常不能按时供货；6.7.1.3.7 If vendor fails to meet the requirement after warning.警告后供应商仍不能达到相关要求；6.7.1.3.8 If more than three major on a particular material (repetitive in three months) from the same vendor shall be treated as critical.如果来自同一个供应商的一

37、种物料发生了三种以上的常见问题（3个月内重复发生）就应当被视为关键问题。6.7.1.3.9 Out of trend results 偏离趋势的结果6.7.1.4 The vendor shall be communicated immediately for the respective issues. Based on the reply and action taken by the vendor, the vendor shall be warned and site audit may be required.应当及时和各供应商沟通他们所存在的问题，根据他们的回复以及所采取的措施，决

38、定是给予警告还是需要进行再审计Major issues shall be closed within 60 working days.主要问题应当在60个工作日内解决。6.7.1.5 Minor微小的6.7.1.5.1 Other than the above circumstances, any other issues arising shall be treated as minor.除了上述问题，其余问题均被认为是次要的问题。6.7.2 During course of evaluation/reauditing, if any information provided by the

39、vendor is found untrue/false or misleading or any change carried out is not informed in writing the vendor shall be disqualified after proper investigation.在再审计和评估的过程中，如果供应商提供的信息一旦被发现是不真实的、错误的、误导性的或发生了没有声明的变更，在经过调查确认后，可撤销该供应商的资质。6.7.3 If any vendor is disqualified the approved vendor list shall be u

40、pdated immediately and the revised copy shall be circulated to the concerned department.任何供应商的资质被撤消后，批准的供应商列表应及时更新，并将更新后的版本发放给各相关部门。6.7.4 If any material is rejected due to quality issues, it shall be handled as per the procedure X-SOP-QA038 Handling of Out of Specification (OOS) test results. 如果有物料由于质量问题被退回，这种情况应当按照X-SOP-QA038 OOS管理规程进行处理。6.8 Vendor audit reports shall be numbered as follows: No. VR/XX/YY001Where, VR indicates Vendor audit reports, XX indicates RM / PM for Raw Material and Packaging Material respectively. YY indicates last 2 digit of year eg. 10 indicates 2010, 001 in