某上市公司供应商的选择与批准程序中英对照

毒手药王

题    目：供应商的选择与批准程序 Title: Supplier Selection and Approval Procedure	编    号：5-00060-11 Code
制 定 人： Author	制定部门：QA Dept: QA	制定日期：   年 月 日 Drafted Date
技术审核人： Technical Checker	审核部门：质量管理部 Dept: Quality Management Dept.	审核日期：   年 月 日 Reviewed Date
技术审核人： Technical Checker	审核部门：生产供应部 Dept: Material Supply Dept	审核日期：   年 月 日 Reviewed Date
技术审核人： Technical Checker	审核部门：制造部 Dept: Manufacturing Dept	审核日期：   年 月 日 Reviewed Date
符合法规性审核人： Compliance Checker	审核部门：质量管理部 Dept: Quality Management Dept.	审核日期：   年 月 日 Reviewed Date
文件格式审核人： Checker of File Format	审核部门：QA Dept: QA	审核日期：   年 月 日 Reviewed Date
批准人： Approver	批准人：总经理助理（分管质量） Person: Associate General Manager of Quality	批准日期：   年 月 日 Approved Date
颁发部门：质量管理部 Issued by: Quality Management Dept.	生效日期：      年     月     日 Effective Date
复审日期：      年     月     日 Recheck Date
分发部门 Dispensed to	分发份数 Copies Dispensed
质量管理部 Quality Management Dept.	3
总工程师办公室 Chief Engineer Office	1
制造部 Manufacturing Dept.	1
生产子公司 Manufacturing Affiliates	各1份
药物研究院 Drug Research and Development Dept.	1
中药研究院 TCM Research and Development Dept.	1
生产供应部 Material Supply Dept.	1
化验室 Quality Control Center	1
计量处 Metrological Laboratory	1
生产和辅助车间 Production and Ancillary Workshop	各1份
物料仓库 Material Warehouse	2
成品库 Finished Product Warehouse	1

一．目的Objective

为我公司药品生产所使用的物料及规定的辅助物料的供应商建立选择程序和批准程序，主要包括资质要求、选择的原则、质量评估的方式、评估合格的标准等，以确保我公司产品所使用物料的安全可靠性。

To establish a supplier selection and approval procedure for materials and designated auxiliary materials  to ensure the safety and reliability of the quality of materials used in our products. The procedure includes qualification requirement, principles for selection, quality evaluation and standards for qualification

二．适用范围Scope

适用于如下物料及规定辅助物的供应商（含生产商、经销商或代理商）的选择与新增程序：

Applicable for Selection and Approval Procedure of the following material and designated auxiliary material suppliers (manufacturer, distributor or agent):

1.原料：包括化学药品制剂的原料即原料药；生物制品的原料即原材料；中药制剂的原料即中药材、中药饮片和外购中药提取物。

Raw material: Including raw materials of chemical preparations namely API; raw materials of biological products namely raw materials; raw materials of Chinese medicine namely Chinese herbal, Chinese herbal medicine and purchased herbal extracts.

2.辅料：除了原料和包装材料之外，药品生产中使用的任何物料。

Excipient: any material used in the production of drugs, except for raw material and packaging materials.

3.包装材料：药品包装所用的材料，包括与药品直接接触的包装材料和容器、印刷性和非印刷性包装材料，但不包括发运用的外包装材料。其中印刷性包装材料指具有特定样式和印刷内容的包装材料，如印字铝箔、标签、说明书、纸盒等。

Packaging material: materials used for pharmaceutical packaging, including the packaging materials and containers which directly contact with drugs, printed and non-printed packaging materials except the packaging materials for shipping. The printed packaging materials refer to the packaging materials with specific pattern and printed content, as printing aluminum foil, label, instruction, carton, etc.

4.规定辅助物：主要指无菌制剂直接接触药品的医疗器械、气体；生产用过滤器、清洁剂、消毒剂；洁净装备（乳胶手套/一次性手套/洁净服/洁净鞋），滴眼剂瓶用聚氯乙烯颗粒、冷链包装（含冰袋）；微生物及无菌检测用培养基、集菌器、设备所用润滑剂、冷却剂；医用包装用Tyvek/聚乙烯洁净袋；验证用无纺棉等。

Designated auxiliary materials: as medical devices or gas which direct contact with sterile preparations; production filters, detergents, disinfectants; clean equipment (latex gloves/ Disposable gloves/clean clothing/clean shoes), PVC particles used for eye drop bottle, cold chain packaging (containing ice packs); mediums which used for microbiological and sterility testing, set bacteria filter, equipment lubricants and coolants; Tyvek/ polyethylene clean bags used for medical packaging and so on.

三．责任者Responsibilities

1.质管部：Quality Management Dept.:

－QA巡检员：参与物料试用方案的审核，根据批准的方案对试用过程进行监控，对试用结果进行确认和评价；

QA Inspector：Participate in the review of material trial plan, monitor the trial process according to the approved plan, and evaluate the trial results.

－QC：根据批准的物料质量标准及检验操作规程，对采购物料进行取样、检验；对试用或验证产品进行取样、检验和稳定性考察，提供各供应商物料检测数据；对前期筛选阶段的A类、B类物料中的非无菌制剂辅料的小样进行检测，在评估表中填写检测结果。

QC: Sample and test the purchased material according to the approved material quality specifications and inspection procedures; sample, test and do stability test to samples for trial or validation, then provide test result; test samples of Class-A material or exicipients for non-sterile preparation in Class B materials during the preliminary screening stage, then provide test result  in  assessment forms.

－QA：对前期筛选阶段的A类、B类物料中的非无菌制剂辅料的小样检测数据与以往检测数据进行对比，在评估表中填写对比结果。

QA: contrast inspection data of the excipient samples of non sterile preparation of the preliminary screening class-A、class-B materials with historical data, then fill the comparing results in the assessment table.

－供应商管理员：负责形式审查供应商基础信息，负责对物料选择和评价的过程进行跟踪、登记、下发、建档等。

Supplier Administrator：responsible for file inspection about supplier’s basic information, responsible for conducting tracking, registration, issued and filing in the material selection and evaluation process.

－QA主管：组织协调供应商的评审工作，编写供应商质量保证协议，对新物料试用进行评价，供应商审计计划组织执行。

QA supervisor: organization and coordination of supplier assessment, write supplier quality assurance agreement, evaluation trial of new materials, organize supplier audit plan execution.

－质管部部长：签署供应商形式审查报告的终审意见，签署新物料试用评价的终审意见。

Manager of Quality Management Dept.: sign the final comments of supplier file inspection report, sign the final comments of trial evaluation of new materials.

－质量受权人：物料供应商的批准或否决。

QP: Supplier approval or rejection of materials.

2.生产供应部：负责供应商的前期筛选、供应商基础信息的收集和调查、供货价格谈判、采购合同、供应商质量保证协议签订、物料采购等全过程的组织和管理工作，协助完成供应商审计。

Material Supply Dept.: responsible for pre-screening suppliers, collect and investigate supplier base information, supplier price negotiations, procurement contracts, sign supplier quality assurance agreement, material procurement and other organization or management, assist in completing audit of the supplier and annual comprehensive assessment of suppliers.

3.制造部：负责按照经批准的物料试用评价审批意见开展相关工作并进行评价。

Manufacturing Dept.: responsible for carry out related work and evaluate in accordance with the approved comments of materials trial evaluation.

四．相关定义Definition

1.物料：指原料、辅料和包装材料等。

Material: raw materials, excipients and packaging materials.

2.印刷包装材料：指具有特定式样和印刷内容，并经药品监督管理部门批准的包装材料，如印字铝箔、标签、说明书、纸盒等，纸箱参照印刷性包装材料进行管理。

Printed packaging material: means packaging material with specific pattern and printed content and approved by drug regulatory agency, as printing aluminum foil, label, instruction, carton, etc, outer package’s management refer to printed packaging material.

3.供应商：本SOP规定为药品生产所用物料的提供方，如生产商、经销商或代理商。

Supplier: means providers of materials used in drug production in this SOP, as manufacturer, distributor or agent.

4.最小批量试用评价：指用能够满足设备最小生产性能的批量或车间工艺规程中经过批准的最小生产批量进行试用评价的过程。

Minimum batch trial evaluation: means use the minimum lot size which can meet equipment performance or the approved minimum lot size in master production procedure to conduct trial evaluation.

5.正常批量试用评价：指用生产工艺规程中经过批准的正常生产批量进行试用评价的过程。

Normal batch trial evaluation: means use the normal batch which approved in master production procedure to conduct trial evaluation.

6.待评价物料供应商：待评价物料供应商主要指新品研发拟报临床或生产批件阶段的产品物料供应商及用于新物料引进处于评价阶段的物料供应商。

Material suppliers awaiting assessment：The material suppliers awaiting assessment mainly refer to suppliers whose materials are used for applying for the stage of the clinical trials of new drug R&D or Production approval and suppliers whose materials are in the stage of evaluation of new introduced materials.

五．工作程序Procedure

1.物料分类Materials Classification

类别 Categories	物料Materials
A类 Class A	无菌制剂用原料药及辅料；非无菌制剂原料药；无菌制剂直接接触药品的内包装材料；非无菌制剂大宗辅料（占制剂处方量的30%以上）等 Raw materials and excipients for sterile products; Raw materials for non-sterile products; Primary packaging materials directly contacting with sterile products; Staple excipients (more than 30% in manufacturing formula of preparations ) for sterile products etc.
B类 Class B	非无菌制剂直接接触药品的内包装材料；非无菌制剂辅料（占制剂处方量的30%以下的）；空心胶囊；制剂中食品添加剂；中药材和中药饮片等 Primary packaging materials contacting with non-sterile products; Excipients for non-sterile products (no more than 30% in manufacturing formula of preparations); Empty capsules; food additives for preparations ; TCM and  decoction pieces etc.
C类 Class C	制剂中化学试剂；印刷性包装材料；吸管等 Chemical reagent ; Printed packaging materials; suction tubes etc.
D类 Class D	非印刷性外包装材料（吸塑、垫片、避光袋、打包带等） Non-printed secondary packaging materials (Skin packaging, gasket, black-out strip etc.)
E类（辅助物料） Class E (Auxiliary  materials)	高风险 High-risk	无菌制剂直接接触药品的医疗器械，如输液器；与药品直接接触的气体；生产用过滤器；空气净化用高效过滤器；生产用清洁剂\消毒剂等 Medical apparatus and instruments directly contacting with sterile products, such as; Air directly contacting with products; Filters for production;  High efficiency filters for air purification; Cleaning agent or disinfecting agent for manufacturing etc.
中风险 Medium risk	洁净装备(乳胶手套\一次性手套\洁净服\洁净鞋) ；滴眼剂瓶用聚氯乙烯颗粒；冷链包装（含冰袋）；医用包装用Tyvek/聚乙烯洁净袋；验证用无纺棉等 Cleaning appratus (milk meeting set\disposable glove\protective clothing\protective shoes) ; Polyvinyl chloride (PVC) particles for eye drops bottles ; Cold chain packing (cooler bag included); Tyvek or protective bags for medical use, cotton for validation etc.
低风险 Low-risk	微生物及无菌检测用培养基、集菌器、设备所用润滑剂、冷却剂等 Culture media for microorganism testing, microbial-collecting apparatus, lubricating agents for machines, coolant etc.

2.物料的选择The selection of materials

2.1.供应商前期筛选Primary screening of suppliers

2.1.1.筛选前生产供应部采购员填写《物料供应商前期筛选表5055》，明确选择供应商的原因，如现供应商供货质量状况不稳定、增加备用供应商、所选供应商在行业内创新运用先进技术、所选供应商在行业内同等质量情况下供货能力及价格因素、我公司质量标准发生变化、其它原因等；

Before starting a screening, purchasers in the Material Supply Dept. should fill a form “Primary Screening of Materials Suppliers Record5055”, to make it clear that in which circumstance we need to  purchase the material. The unstable quality of formal supplier, adding a secondary supplier, the latest technology being used in its company ,the supply ability and price factor Under the condition of the same quality, changes of our company quality standards and many other situations may be included in our consideration.

2.1.2.根据所选原因，生产供应部采购员在描述栏内具体描述供应商所属行业状况、所选供应商具体信息、是否符合我公司产品报批要求、是否满足质量标准要求、生产能力能否满足我公司要求、与当前正常供货的供应商在质量/技术/成本/价格/市场等方面的比较，并提出对所筛选公司后续是否开展小样检测、是否具备现场动态审计条件、是否提供相应资质审查材料等基础信息。对于A类、B类物料中的非无菌制剂辅料，需先进行质量评估，生产供应部将3批供应商出厂检验报告附于《新物料质量评估表50113》中，并提供3批报告批次的其中一批供QC检测；QC对该批小样按照我公司质量标准进行检测，在评估表中填写检测结果；QA对小样检测数据及厂家出厂检验报告与我公司以往检测数据进行对比，在评估表中填写对比结果，原则上新供应商的检测数据不得低于现有供应商水平。对比评估完成后，生产供应部采购员将该评估表附于《物料供应商前期筛选表5055》后，随《物料供应商前期筛选表5055》一并流转。

According reasons described above, in the description section purchasers in Material Supply Dept. should concretely describe the following aspects: industry conditions to which suppliers belong, specific information of suppliers ,if it conforming to content of submission for approval of our products, if it contenting quality standard approved, if its productivity contenting us, comparison of quality, technology, cost, price, market etc. between current and the former supplier, and proposing the basic information that if it launching small sample inspection ,if there being dynamic audit conditions, and if it providing related qualification examination data. For Starting materials for non-sterile products of class A and class B, production supply department should carry on the quality appraisal at first, attaching 3 batches materials inspection report from suppliers to the form “The New Materials Evaluation Record 50113” and provide a small sample to QC to test. Then QC according to our quality standard has a test for it and record related t testing result. QA compare the report and testing result with the former, record the comparing result in the form, ensuring relevant data quality not less than current supplier. After evaluation, the form should be attached to “Primary Screening of Materials Suppliers Record 5055”, flowing together.

2.1.3.如果供应商质量标准与我公司物料质量标准不一致，生产供应部应负责与供应商联系，并与我公司质管部、制造部共同商讨标准确定问题，应达成一致意见，生产供应部以书面形式报经质管部部长批准，内容包括修订标准、单独编制标准，或以供应商标准进行检测等，以附件形式附入《物料供应商前期筛选表5055》中。

If the quality standard provided by the supplier is not in accordance with the standard the quality our company agrees to, Material Supply Dept. should contact the supplier, consulting with Quality Management Dept. and manufacturing department on judging a successful negotiation, to reach a consensus. Then a written form is presented to the manager of Quality Management Dept. for approval, including the revised standard, self-made standard or the supplier testing standard, and then being post on the record “Primary Screening of Materials Suppliers Record5055”in the form of attachment.

2.1.4.《物料供应商前期筛选表5055》的流转Flowing of the record “Primary Screening of Materials Suppliers Record5055”

－生产供应部采购员将《物料供应商前期筛选表5055》送主管进行技术审核，经生产供应部负责人签署部门审批意见，流转至制造部签署相关部门意见，对新物料后续的试用评价方式进行评估，根据物料对产品质量影响的大小以及质量评估对比结果，评估意见可包括：①开展小试；②进行3批最小批量试用；③进行3批正常批量试用；④开展或同步开展稳定性考察；⑤开展验证；⑥不需开展试用工作，形式审查合格、现场审计合格后正常使用；⑦其它等。

Purchasers send the “Primary Screening of Materials Suppliers Record 5055” to supervisor to complete technical review. After the head of production supply department signed opinions on reexamination, the record flow to manufacturing department signing opinions on reexamination as well. These reexaminations may contain evaluations of the evaluation mode of following materials use, and compare results according to the material influence on product quality and quality assessment ,including the following assessment : ① launching lab experiment ;② carrying on attempt trial of 3batches Min Lot Size ;③launching attempt trial of 3 normal batches;④launching synchronously or launching stability study;⑤launching validation;⑥not launching any attempt trial, just being used normally after the file inspection  and an on- site audit proved qualified;⑦ others.

－对于已开展三批工艺稳定性考察待报批的新产品变更供应商的情况，需要药物研究院部门负责人签署意见；若新物料用于新品报批或新产品正式投产工艺交接前品种，药物研究院应签署新物料对产品质量影响的评估意见，制造部签署相关部门意见。

For new product what had been launched three batches process stability study to be submitted for approval, if there is a change for supplier, suggestion signed by the head of Drug Research Institute is a must. When new materials are used to new products submitted for approval or when used to formally put into production before technology transition, Drug Research Institute should sign assessment views that how new materials affect product quality, and manufacturing department signs relevant opinions as well.

－相关部门签署意见后，交质管部QA主管进行初步审核，最终经质管部部长签署审批意见。

After views signed by relevant department ,the record should be transferred to QA supervisor to Conduct primary audit, then passed on to the manager of Quality Management Dept. to sign final opinions.

－流转《物料供应商前期筛选表5055》时，应将供应商的基础形式审查资质材料附入，具体要求见《物料供应商前期筛选表5055》（此部分材料可接收传真件，加盖供应商鲜章（红章或蓝章）的材料及形式审查所需的其他资料可待《物料供应商前期筛选表5055》批准后向供应商索要）。

When the record flow from person to person, materials for file inspection should be attached. Refer to “Primary Screening of Materials Suppliers Record5055” for more details. (These materials can be accepted in the form of fax. After the record was approved, production supply department in time should ask for materials covered the red company seal and and that will be used in other formal examination.)

2.1.5.《物料供应商前期筛选表5055》编号方式：QQSX+年份（四位数）+流水号（三位数），如QQSX2011001。

“Primary Screening of Materials Suppliers Record 5055”code: QQSX +year (four-digit) +serial-number (three-digit), for example, QQSX2011001.

2.1.6.《物料供应商前期筛选表5055》原件由供应商管理员存档，同时下发一份给生产供应部。

The original “Primary Screening of Materials Suppliers Record5055” is in the charge of supplier administrator, and one copy should be distributed to Material Supply Dept.

2.2.变更Changes

物料 步骤	A	B	C	D	E	相关管理规定 Related administrative regulations
变更计划 plan of change	对于A、B、C类物料，经质量管理部部长同意引进后，生产供应部提出变更计划，将《物料供应商前期筛选表5055》复印件一同附入部门月度变更计划中，在月度变更委员会会议中讨论，申请内容应明确是否进行小试、直接开展最小批量试生产或正常批量生产，并提出稳定性考察和办理补充申请建议。 For materials of class A, B or C, which is approved by the manager of of Quality Management Dept., Material Supply Dept. should attach the change of plan to monthly change plan together with the “Primary Screening of Materials Suppliers Record5055” copy. There will be a discussion of application details in the monthly meeting of change plan. We should make it clear that if there should be necessary for a pilot trial, if it is feasible to immediately carry out attempt production of Min Lot Size or formal production, and advises launching about stability study and conducting supplementary application	D、E类物料，经质量管理部部长同意引进后，不需提交变更计划，生产供应部直接填写《变更审批表5117》按《变更控制规程5-00066》要求流转审批，同时将《物料供应商前期筛选表5055》复印件附入变更审批表中。 For class D and E approved by the manager of of Quality Management Dept.manager of Quality Management Dept., Material Supply Dept.need fill the record “The Change Approval Sheet5117” without providing the change of plan and transfer it to others according to the file “ change control procedure 5-00066” and should attach a “Primary Screening of Materials Suppliers Record5055”copy to the sheet.	对于拟新增的物料，生产供应部向供应商采购或索要小样送化验室进行检验，小样采购运输过程应符合物料贮存要求，检验报告应附入《物料供应商前期筛选表5055》中。特殊情况下，生产供应部在《物料供应商前期筛选表5055 》提出，经质量管理部部长批准后可提前进行小样检验。 For the proposed new materials, Material Supply Dept. should send the sample purchased or asked for from the supplier to the laboratory. Procurement and transportation of the sample should conform to material storage requirements. After the test, the test report also should be attached to the record “Primary Screening of Materials Suppliers’ Record 5055”. In some particular cases, the department can claim an advanced test approved by the manager of Quality Management Dept. in light of the record 5055.
执行变更程序change execution	对于变更委员会同意增加的候选供应商，由生产供应部填写《变更审批表5117》按《变更控制规程5-00066》要求流转审批，同时将《物料供应商前期筛选表5055》复印件附入变更审批表中。 For the candidate supplier approved by the change committee, Material Supply Dept. should fill the record “The Change Approval Sheet5117” and transfer it according to “The Change Control Procedure 5-00066” .Also the record “Primary Screening of Materials Suppliers’ Record 5055” copy should be attached to it.

2.3.形式审查File inspection

2.3.1.对于最终批准同意增加的供应商，由生产供应部向供应商提供相关物料《物料供应商基础信息调查表》，根据调查表的要求收集相关的基础性材料。生产供应部需在变更下发后一周内将收集的材料流转至质管部供应商管理员处进行审核。

For the final supplier approved, the supplier should be provided by Material Supply Dept. with the sheet “The Basic Information Survey Sheet of The Material Supplier “, according to which the basic information should be collected. Material Supply Dept. needs to transfer the collected materials to be checked by the supplier administrator in Quality Management Dept. within one week after the change issued.

2.3.2.生产供应部采购员在提交基础材料前应对《物料供应商基础信息调查表》及资质材料初审，生产供应部主管审批并签署意见，初审完毕后交质管部供应商管理员。供应商管理员按《物料供应商基础信息调查表》上要求提供资料进行审核，填写《物料供应商形式审查表5101》中资料审查结果和整改确认情况，符合要求后交QA主管审批，QA主管审批后交质管部部长最终审批，判定形式审查是否合格。若合格则应明确后续需开展哪些活动，如送样检测\小试\最小批量试用\正常批量试用\批量试用前现场审计\正式投入生产前现场审计\正式投入生产后6个月内现场审计\形式审查合格，不需现场审计\其它等；若不合格，则拒绝增加。对于部分急用但形式审查资料不能及时提供完全的情况（物料前期筛选表上要求的基础形式审查资料必须已提供完全），可限期整改。形式审查主要审查内容见附录一。

Before submitting the basic information, purchasers should show a primary inspection to the sheet and qualified data, and opinions and an approval from the supervisor of Material Supply Dept. is a must, and then transfers it to the supply administrator of the Quality Management Dept.. In the light of the request of the sheet, the administrator shall process approval on the basis of relevant data, and fill out items of result of data inspection and rectification conform situation in the sheet “File Inspection Form for Supplier  5101”. When proved feasible, transfer it to QA supervisor for an approval, and then flow it to the manager of Quality Management Dept. to get an inspection for approval concluding whether it is qualified or not . If it contents the company, we shall make sure what activities should be next launched, such activities as sample testing\lab experiment\attempt trial of the Min Lot Size\attempt trial of 3 normal batches\an on- site audit before attempt trial of batches\an on- site audit before formally manufacturing\an on- site audit in 6months after formally manufacturing\qualified inspection for approval without an on- site audit\others. If not, turn them down. Considering the part in urgent need but no form inspection data in time(on condition that the basic form inspection information “Primary Screening of Materials Suppliers Record5055” demanded has been provided), a timely rectification is acceptable. Main contents of the form inspection are available in Appendix 1.

2.3.3.《物料供应商形式审查表5101》最终需经质管部部长审核批准。质管部部长签署意见完毕后，供应商管理员复印分发至生产供应部，与其他部门相关时，应复印分发给相关部门。

“File Inspection Form for Supplier  5101” finally needs to be approved by the manager of Quality Management Dept. After being signed for constructive opinions, its copies should be distributed to Material Supply Dept. as well as other relevant department if necessary.

2.3.4.《物料供应商形式审查表5101》编号方式：XSSC+年份（四位数）+流水号（三位数位数），如XSSC2011001。

“File Inspection Form for Supplier 5101” code: XSSC+year (four-digit) + sequence number (three-digit). XSSC201101 is an example.

2.4.现场审计on- site audit

2.4.1.根据质管部部长批准的《物料供应商形式审查表5101》意见，生产供应部应与供应商联系确定时间，及时向质管部提出对供应商现场审计的申请，具体对供应商现场质量体系的评估要求，按照《物料供应商现场审计程序5-00061》执行。

According to opinions about “File Inspection Form for Supplier 5101”approved by the manager of Quality Management Dept., Material Supply Dept. should contact the supplier for negotiating the time when the department of quality request an application of an on- site audit without delay. To get concrete appraisal requirements for the quality system of manufacturing site of the supplier, executing the procedure “The On-site Audit Procedure of The Supplier5-00061” is a must.

2.4.2.对集团内公司B、C、D、E类物料，若存在相同供应商，且对物料的用途和要求一致，审计时对物料供应商按照同一标准或高于需求的标准进行审计，原则上可免于现场审计。由QA向集团内其它公司质管部索取现场审计报告复印件（含供应商整改报告）至我公司供应商管理员处，经质管部部长确认批准后作为审计依据。

For the materials class B,C,Dand E to be purchased in the company of pharmaceutical group, if there exists the same supplier , and the same purposes and requirements for the materials, an on- site audit is not necessary in principal ,at least to guarantee the audit process with the same or even higher standard. QA is responsible for asking for on-site audit report copies from other Quality Management Dept.s of subsidiary companies of the group and deliver them to the supplier administrator, the copies being approved by the minister of Quality Management Dept. as the auditing basis.

2.4.3.集团内的A类物料的供应商，必须在批量试用前/正式投入生产前现场审计。对于B、C、D类物料中需进行现场审计的供应商，原则上应审计合格后方可正式投入使用，特殊情况下，可在正式投入使用后6个月内进行现场质量审计，但需经质管部部长批准。

For suppliers of materials in Class A, on site audit must be carried out before trial use in bulk or formal production. For those suppliers of materials in Class B, C and D that need to be on-site audited, generally audit should be carried before formal production. In specific situations, on-site audit can be carried out in 6 months after formal production involving the materials. However, these cases should be approved be the minister of Quality Management Dept.

     2.4.4.不能按期完成审计的，由QA主管或生产供应部采购员填写《供应商审计延期 申请表50069》，并经质管部部长批准（因质管部人员安排的，由QA主管提出；因供应商问题的，如不具备审计条件，由生产供应部采购员提出）。

If on site audit cannot be completed as required, “Application Form for Supplier Audit Extension 50069” should be filled by QA supervisor or purchasers and approved by Manager of Quality Management Dept. (If the extension is due to the management in Quality Management Dept., it should be proposed by QA supervisor; if it is due to suppliers, it should be proposed by purchasers).

2.4.5.对于进口物料及部分不具备现场审计条件的国产物料，可对该物料经销商或代理商进行现场审计，主要对仓储、运输等条件进行考察。

For imported materials or partial domestic materials which could not provided with an on- site audit, instead we should make an on- site audit from the material dealer or agent, investigating conditions of storage and transportation.

2.5.试用评价

2.5.1.确定试用方案程序determine the trial program

－形式审查合格后，生产供应部结合形式审查、变更委员会及变更审批表意见，生产供应部采购员从《物料小试评价表5100》、《物料最小批量试用评价表5441》、《物料正常批量试用评价表5442》中选择合适的表格，填写评价表中“＝”以上部分，经主管签署意见，交质管部供应商管理员。

After file inspection , the purchasers of Material Supply Dept. should chose the right form from “The Evaluation Form of Lab-scale Test of Materials 5100”, “The Evaluation Form of Minimum Lot Size Trial of Materials 5441” and “The Evaluation Form of Normal Batch Trial of Materials 5442” to fill out the part above level ‘=’, obtaining opinion signed from supervisor and then transfer it to the supplier administrator of Quality Management Dept..

－供应商管理员应在评价表中对是否已进行形式审查，前期小试评价、最小批量试用及正常批量试用后续开展试用问题整改的情况进行确认。

The supplier administrator should carry out a conformation about if there is a file inspection, primary lab-scale test and attempt trial of minimum Lot Size, and the rectification in the following steps of normal batch trial.

－QA主管明确后续需开展的工作，如物料检验、试用方案、产品稳定性考察等的具体要求。

QA supervisor identifies further work, for example, material inspection,  trial plan, product stability test etc.

－供应商管理员将物料试用评价表下发至车间，车间根据QA主管签署意见在给定期限内完成试用方案的制定，方案经QA巡检员、制造部技术主管、药物研究院注册组组长审核后，交质管部QA主管审核、质管部部长批准。

The supplier administrator distributes the evaluation form of material trial to the workshop, and the workshop should complete the trial plan in a given period according to opinions signed by QA supervisor. After auditing from QA inspection staff, technical director of the manufacturing department and the registration team leader the Institute of Pharmaceutical Research, the plan should be transferred to the minister of Quality Management Dept. for approval.

2.5.2.试用要求trial requirements

物料 项目	A	B	C	D	E
小试lab-scale-test	可开展1-3次的小试，小试合格后进入最小批量或正常批量试用评价阶段 Carrying out 1-3 times lab-scale-test. If passing tests, the materials can enter the minimum or normal volume trial evaluation phase.	不需开展小试 Not carrying out lab-scale-test	根据物料行业规范确定检验、试用要求。 According to industry specifications to determine material testing, trial requirements.
最小批量试用minimum lot trial	① 对于制剂原料、辅料，应至少开展3批最小批量或正常批量试用评价、工艺验证（试用评价可与工艺验证同步进行），生产的制剂应开展加速和长期稳定性考察。 For raw materials and excipients of the preparations, the new materials should be carried out for trial evaluation and process validation of 3 minimum batches or normal batch trial (trial evaluation can be carried out simultaneously with the process validation).Production preparations should carry out accelerated and long term stability test. ②对于无菌制剂直接接触药品的包装材料、非无菌制剂直接接触药品的包装材料，应开展连续3批最小批量或正常批量试用评价；材质发生变化的，需同步开展包材与药品的相容性试验，并按省药监部门相关文件要求办理补充申请工作； For Immediate packaging materials contacted to non-sterile products, the materials should be continuously carried out for 3 minimum batches or normal batch trial evaluation. And if the material quality changes, there is a need to carry out synchronization and drug packaging materials compatibility test, and related departments should process supplemental applying  according to the provincial pharmaceutical sector related documentation requirements . 对于供应商发生改变的内包材均需开展包材与药品的相容性试验，其中对变更注射剂药品药用玻璃包装生产厂家的，在完成相容性试验后，按省药监部门相关文件要求办理补充申请备案工作。药用玻璃生产发生原料、处方、工艺等变更时，应重新进行药品与药用玻璃的相容性试验。 There is a need to carry out synchronization and drug packaging materials compatibility test if the supplier changed the Inner packing material. For the change to injection drugs pharmaceutical glass packaging manufacturer, related departments should process supplemental application filing work after compatibility test. If there are changes to row materials ,prescription, technology and others, reopening compatibility test is a must ③B类中的中药材及中药饮片的试用工作，可不进行小试，可直接批量试用，试用批次需10批次及以上方可进行评价总结，评价总结需增加仓库验收人员、QC签署意见。 For the trial work of Chinese herbal medicines and Chinese Herbal Medicine of Class B, can carry out lab-scale-test or batch trials. The batch trials can be evaluated and summarized by 10 or more batches. The summary evaluation need to add the warehouse inspection staff and the QC signed opinions.	①可直接开展最小批量试用或正常批量试用，试用批次具体由质量管理部长决定，但若连续开展三次试用仍不合格，不得再次进行试用。 The minimum or normal volume trial can be directly carried out, And the specific trial batches are determined by the Minister of Quality Management Dept.. However, carried out three consecutive trials if not unsatisfactory, it will not be tried again. ②不需要开展验证、稳定性考察和补充申请 Without carrying out validation, stability test and supplemental applying	直接试用生产3批产品 Carry out trial production of three batches directly.
正常批量试用normal batch trial
对于拟报批产品使用的物料，可不进行试用工作. 详见2.9.中待评价物料供应商的相关流程。 For the product to be submitted for approval to use the material, do not carry out trial work. See 2.9. the relevant processes of the material suppliers awaiting assessment.
备注：对于制剂原料、辅料、与药品直接接触的包装材料需办理供应商变更补充申请的，应按照《药品注册管理办法》和省药监部门相关文件要求办理供应商变更补充申请工作。 Note: For the preparations of raw materials, excipients, and inner packaging materials that need to be processed supplier change supplemental application, we shall follow the "Drug Registration” and the provincial pharmaceutical sector related documentation requirements to work.

      2.5.3.试用过程管理Trial Process Management

－小试及批量试用均应编制试用方案，试用方案应包括：产品名称\规格\批量\投料量\批次数\试用步骤和操作参数要求\关键验收项目及验收标准\验收记录\拟实施时间等。具体参见《新物料试机方案管理程序5-00174》

Lab -scale-test and batch trial both shall be established a trial Program and the Program should contain: product name\Specification\Batch\Feeding amount\Batch Count\Trial procedures and operational parameters requirements\Critical acceptance of the project and acceptance criteria\acceptance records\Time to be implemented etc. See more details in “Management Procedure for New Material Trial Plan 5-00174”

－物料经检验合格后，生产供应部将车间试用方案及物料试用评价表原件（附供应商物料检验报告）流转至车间，车间凭领料单和物料试用评价表从仓库领取试用物料，根据已批准的试用方案组织人员对样品进行试用，及时做好试用过程记录（可以是批生产记录）。

After materials passing inspection, the trial program and original materials trial evaluation form (attached supplier material inspection report) should be transferred to the workshop by Material Supply Dept. The workshop receives trial materials from the warehouse with material requisition and materials trial evaluation form. According to trial program approved, related personnel’s have a trial for the sample and keep timely records in the entire process.

－试用后产品，由经授权的人员负责成品取样，QC按相关产品成品质量标准进行检验，有特殊要求的，应增加相关项目的检测。

After the trial, and the finished products being sampled by the personnel authorized, QC carry out the testing according to related Product quality standards. If there are special requirements, the one should increase the detection of relevant items.

－车间结合检验报告和试用情况在相应物料试用评价表中填写试用结果，物料试用评价表连同试用方案、试用记录、检验报告等在试用结束后3个工作日内，流转至QA巡检员对试用结果进行确认，需要进行稳定性考察的应在6个月考察结果合格后3个工作日内将物料试用评价表、试用方案、试用记录、检验报告、稳定性考察报告等流进行流转审批。

Trial results should be filled in the corresponding materials trial evaluation forms according to inspection report and trial situations..After that, the materials trial evaluation form should be transferred to QA inspection staff to conform the trial results together with the trial program, the trial records, and inspection reports in three working days. For materials that need stability test,  apart from the above-mentioned items, the stability test report need also to be transferred for approval in three working days after 6 months’ stability test.

－试用物料、产品、检验样品和留样，车间应做好现场状态标识，保证和正常生产使用的物料和产品进行有效的隔离，防止出现混淆。对于小试试用后的剩余物料及产品，应执行《不合格品处理单5121》按《不合格品处理规程5-00068》处理，并有相应的销毁记录。

For trial materials, products, test samples and retention samples, the workshop should be prepared on-site state identification, to ensure an effective isolation for normal production and use of materials and products, and to prevent confusion. For Surplus materials and products after lab-scale-test, “The Nonconforming Product Processing Form 5121” should be executed according to “The Nonconforming Product Processing Procedure 5-00068”, keeping corresponding destruction of records.

－批量试用的工艺及生产设备应采用正常生产的经批准的产品工艺及设备，小试设备可以与正常生产的设备有所不同，但小试工艺步骤应与正常生产相一致。

Batch trial process and production equipments should use the normal production process and equipment of the approved products. Equipments of the lab-scale test can be different from normal production, but the kind of steps should be consistent with the normal production process.

－对于最小批量或正常批量试用的产品，可以上市销售，但需根据物料检验、生产过程控制、产品检验及稳定性考察情况以及法规要求进行评价，按成品放行审核程序放行，必要时进行风险评估。

Trial products of minimum batch or normal batch can be used for sale, but they should be legitimately evaluated based on material inspection, production process control, product testing and its stability study as well as regulatory requirements and be released according to the finished products release audit procedure. If necessary, risk assessment is a must.

－一般情况下，对于温度、湿度、光等储存条件有特殊要求的产品，对已试用评价结束后正常生产的第一批应进行长期稳定性试验。

In general, for a storage conditions such as temperature, humidity, light, if products have  special requirements for them, A long-term stability study should be carried out for what have been passed the trial evaluation and Put into normal production of the first batch.

－对于QC正常稳定性考察发现有异常的品种，试用评价的产品应进行稳定性考察。

For Varieties of normal stability study, if QC finds abnormal, products of trial evaluation should be implemented a stability study.

－原则上，连续开展3批试用，若第一批试用物料或产品检验不合格，由QC启动《实验室分析结果超标、超常结果5-00009》；若第一批试用过程发生偏差（包括试用结果不合格），则QA应启动及《偏差管理规程5-00067》，若发现原因为试用物料质量缺陷导致的问题，应停止第二批的试用，若供应商拒绝改进，则不再开展后续试用评价工作；若同意改进，则在改进后重新提供样品开展小试、3批最小或正常批量试用工作。

In principle, the company should carry out 3 consecutive batches trials, and if the first trial for materials or products proved unqualified, QC starts “OOS, OOT 5-00009”.If the first trial process occurs deviation (including unqualified test result); the QA shall start “The Deviation Management Procedure 5-00067”. If the problem is originated from the defects of trial material quality, the workshop shall stop the second trial, and if the suppliers refused to improve, the following trial evaluation will no longer go on. If suppliers accept advices of improvement, they should restart providing samples for the work of carrying out the lab-scale test, 3 minimum or normal batch trials.

2.5.4.评价Evaluation

－QA巡检员对试用结果确认后，流转至制造部技术主管以上、生产供应部主管以上人员签署相关意见，最终经质管部部长签署终审意见。如果质管部部长认为评价需质量受权人签署意见的，则继续流转至质量受权人，质量受权人的意见作为终审意见。

After conform the trial results, the QA inspection staff should transfer it for related opinions of signature to the Manufacturing technical director and supervisors of Material Supply Dept. or those who possess higher position. And eventually the documents should be signed for the final opinion by the minister of Quality Management Dept.. If the minister considers that the evaluation shall be signed by the qualified person, the documents should be flow to the qualified person for the final opinion.

－物料试用评价表原件由质管部供应商管理员存入供应商质量档案，复印件分发至相关部门。

The original material trial evaluation form should be deposited into the quality files of suppliers in the charge of supplier administrators of the Quality Management Dept. And its copies should be distributed to relevant department.

2.5.5.试用评价表编号codes of the trial evaluation forms

－《物料小试评价表5100》编号方式为XSPJ+年份（四位数）+流水号（三位数），如XSPJ2011015。

“The Evaluation Form of Lab-scale Test of Materials 5100” code: XSPJ+year (four-digits) +sequence (three-digit).XSPJ2011015 is an example.

－《物料最小批量试用评价表5441》编号方式为ZXPLPJ+年份（四位数）+流水号（三位数位数），如ZXPLPJ2011015。

“The Evaluation Form of Minimum Batch Trial of Materials 5441” code: ZXPLPJ +year (four-digits) +sequence (three-digit).ZXPLPJ2011015 is an example.

－《物料正常批量试用评价表5442》编号方式为ZCPLPJ+年份（四位数）+流水号（三位数位数），如ZCPLPJ2011015。

“The Evaluation Form of Normal Batch Trial of Materials 5442” code: ZCPLPJ +year (four-digits) +sequence (three-digits). ZCPLPJ2011015 is an example.

2.6.物料采购Material purchase

2.6.1.试用方案批准后，供应商管理员将试用评价表连同车间物料试用方案流转至生产供应部，生产供应部根据批准方案物料用量向供应商采购物料。

After the trial program is approved, the trial evaluation form, together with the program should be transferred by supplier administrator to Material Supply Dept., purchasing materials from the supplier according to approved dosage.

2.6.2.采购数量应至少包括检验及试用量，对于最小批量试用或正常批量试用的应确保试生产三批产品，原则上供应商每批供货批量应与我公司每批产品生产批量一一对应，如有特殊情况，应出具书面说明经生产供应部主管及质管部部长批准后方可执行。

The purchase quantity shall include at least the amount of testing and trial. For materials used for minimum batch trial and normal batch trial, we should make sure it is enough to produce 3 batches products. In general, materials quantity of every batch the supplier provides should be coincident with that our company requires. For any special circumstances, the supplier should provide a written indication to obtain approval from supervisors of Material Supply Dept. and the minister of Quality Management Dept. and then will be accepted.

2.7.入库检验receiving inspection

2.7.1.对于《物料小试评价表5100》中规定不需开展检验的小试样品，仓库根据生产供应部提供的物料试用评价表复印件及收料通知单，接收入新物料仓库。

For lab-scale test sample according to “The Evaluation Form of Lab-scale Test of Materials 5100” without an inspection, the warehouse accepts the new materials in terms of copy of materials trial evaluation form and receiving notice provided by Material Supply Dept..

2.7.2.对于需要检验的小试、最小批量试用或正常批量试用物料，仓库根据生产供应部提供的物料试用评价表复印件及收料通知单，接收入新物料仓库，按照收料、取样及检验、放行管理规程开展相应工作。

For materials used for lab-scale test, minimum batch trial and normal batch trial with an inspection, the warehouse accepts the new materials in terms of copy of materials trial evaluation form and receiving notice provided by the production supply department.  Apart from what is mentioned above, there are also series of operations according to Receiving, sampling and testing, release management procedures.

2.7.3.物料入库后，根据经过批准的质量标准进行检验，对于E类物料，有质量标准可以开展检验的，由生产供应部在《物料供应商前期筛选表5055》中明确应执行的质量标准；若无质量标准可供检验用，可与供应商协商后编制质量标准，或经双方认可的第三方质量标准，如根据供应商委托第三方法定专业检验机构出具的合格报告确定使用标准。

After storage, the materials should be tested according to the approved quality standards. For the materials class E, if there are quality standards for testing, Material Supply Dept. should clearly fill the standards in “Primary Screening of Materials Suppliers’ Record5055”. If there are no quality standards available for testing, our company can consult with the supplier for the quality standards or adopt a third party quality standards both approved. For example, the supplier can entrust a third party statutory professional inspection agency for a qualified report to determine the using standards.

2.8.供应商的批准Supplier approval

2.8.1.供应商批准的前提Premise for  supplier approval

A	B	C	D	E
经形式审查、试用评价、现场审计、供应商在规定期限内完成整改，试生产、工艺验证、稳定性试验考察均合格，按规定已进行备案或完成了供应商变更补充申请且受理通知书下发后 The supplier timely completing rectification after the file inspection, trial evaluation, on-site audit; Proved qualified after trial manufacturing, process validation, stability study. when the acceptance notice for filing or supplemental application of supplier change has been issued	经形式审查、试用评价、现场审计、供应商在规定期限内完成整改，但上述工作若有部分不需要开展的可不进行考察，具体见《物料供应商前期筛选表5055》、《供应商物料形式审查表5101》、《变更审批表5117》相关意见。 Timely completing rectification after the form inspection, trial evaluation, and on-site audit. And if parts of them do not need to carry out ,they are not inspected ，and for details ,see relevant views of the sheet “primary screening of materials suppliers record5055” , "The Form Inspection Sheet of Material Supplier5101”, ”The Change Approval Sheet5117” .	形式审查合格，根据行业规范要求，所需开展的各项工作均完成，具体见《物料供应商前期筛选表5055》、《供应商物料形式审查表5101》、《变更审批表5117》相关意见。The file inspection is qualified and all the procedures needed have been completed. For details, see relevant views of the sheet “Primary Screening of Materials Suppliers Record 5055”, “The Form Inspection Sheet of Material Supplier 5101”, “The Change Approval Sheet 5117”.

2.8.2.供应商批准相关管理规定 Related regulations for supplier approval

－评价合格后，供应商管理员填写《合格物料供应商证书5443》，经质量受权人批准成为正式供应商，复印分发至生产供应部、制造部、仓库、QC，作为物料供应商已正式批准的依据，原件存入供应商客户档案，复印一份附入原变更审批表中予以闭环。

After the evaluation, the supplier administrator fills in “The Certificate of Qualified Material Supplier 5443”, and then transferred it to QP for approval. As the basis for official approval of suppliers, the certificate copies should be distributed to Material Supply Dept., Manufacturing Dept. and the warehouse. The original one should be deposited to the supplier profiles and another copy should be attached to the  change approval form to close related change.

－《合格物料供应商证书5443》作为《合格物料供应商名单5810》的补充件，待下季度下发《合格物料供应商名单5810》时，列入《合格物料供应商名单5810》。

“The Certificate of Qualified Material Supplier 5443” is an additional piece of “The Qualified Material Suppliers List 5810”, and should be listed to it after the list 5810 is issued.

－《合格物料供应商证书5443》编号方式为HGZS+年份（四位数），+流水号（三位数），如HGZS2011005。

“The Certificate of Qualified Material Supplier 5443” code: HGZS+ year (four-digits), +sequence (three-digits), HGZS2011005 is an example.

－《合格物料供应商证书5443》的开具，原则上同一供应商同一物料只开具一张证书，若同一供应商相同类别、且同时评估的合格的物料，可合并开具。

In principle, for the issue of “The Certificate of Qualified Material Supplier5443”, the only one should be issued for the same material of the same supplier. For the materials of the same variety and qualified evaluation of the same supplier, the issue can be combined together.

－若经销商发生变化，而生产商未发生变化的，供应商管理员对生产供应部所提供的经销商资质材料进行评估，根据质量受权人最终评估意见需重新核发的，供应商管理员填写《合格物料供应商证书5443》，经质量受权人批准后复印分发。

If there is a change in the dealers, but no change in the manufacturers, the supplier administrator need an assessment for the dealer’s qualification materials provided by Material Supply Dept. And according to QP’s final assessment, if there is a need for re-issuance, the supplier administrator fills in “ The Certificate of Qualified Material Supplier 5443”, after being approved, then the copies should be distributed to relevant departments.

－如供应商发生重要变更，如原料、配方、关键工艺、厂房发生改变，需由生产供应部按照《变更控制管理规程5-00066》执行变更控制，变更材料中需提供该物料所涉及的产品清单、风险评估报告，对于不可接受的风险需对所涉及的品种进行试用评估后方可正常使用。

If there is any critical change in materials, such as raw materials, formula, critical process or workshop, Material Supply Dept. needs  to initiate change according to the “Change Control Procedure”. A list of products related to the material and a risk assessment report are needed to be provided. When unacceptable risk occurs, materials should be evaluated before use.

2.9.待评价物料供应商的相关管理规定Related regulations for material  suppliers  awaiting  assessment

2.9.1.对于药物研究院拟报批工艺报批确定的供应商，药物研究院应将经课题组组长及负责人签字确认的新产品供应商清单分别复印给生产供应部、仓库和质管部，由生产供应部负责通知供应商填写基础信息调查表，提供相应资质证明材料，经质管部形式审查合格，质管部部长批准，按规定完成了供应商变更申请且获得注册受理通知后，质量受权人签发《合格物料供应商证书5443》，在获得生产批件后正式投入生产前对相应供应商进行供应商现场审计。

For the identified suppliers whose materials used for process approval are approved by Drug Research and Development Dept., the department should copy the new products supplier lists signed by the group leader and person in charge and transfer them to Material Supply Dept., the warehouse and the Quality Management Dept.. Material Supply Dept. is responsible for notifying suppliers to fill basic information form and providing the corresponding qualification materials. And after the supplier passed the file inspection and is approved by QP, timely completing the supplier change application and obtaining notification of acceptance for registration, the Quality Management Dept. is responsible for signing and distributing “The Certificate of Qualified Material Supplier 5443” and should make an on-site audit to corresponding suppliers between the time after production approval and before the materials being put into use.

2.9.2.对拟新品报批工艺报批阶段的物料不需进行试用评价工作，仓库根据药物研究院提供的新产品物料供应商清单及质管部下发的物料形式审查合格报告，接受入新品中试仓库。

For materials the prospective new product use in the stage of Process approval, it is not necessary to carry out trial evaluation work. The warehouse accepts the materials to lie in the pilot warehouse according to the material suppliers list and the report of  file inspection provided by Drug Research and Development Dept.

2.9.3.对已取得注册批件的新品种，在正式投产前\投入生产后需要改变原料\辅料\包装材料供应商的，按2.1.~2.8.的程序，经评价合格后，质量授权人签发合格供应商证书。

For new varieties what have already obtained approval documents, if there is a need to change suppliers before or after official production for changing raw materials\excipients\packaging materials, they should be executed in the light of procedures 2.1-2.8 and the suppliers should be evaluated qualified and signed of Certificate of qualified suppliers by the QP.

六．制定依据Basis

本文件制定依据为《药品生产质量管理规范（2010 年修订）》。

This document is established according to  (GMP 2010).

七．相关文件和记录Related Documents and Records

1.相关文件Related Documents

文件代号 Reference Number	文件名称 Title
5-00061	供应商现场审计程序 The Supplier On-site Audit Procedure
5-00066	变更控制管理规程 Change Control Procedure
5-00067	偏差管理规程 Procedure for deviations
5-00068	不合格品处理规程 Handling procedure of rejected
5-00070	生产过程中不合格品和待处理品的处理规程 Rejected and non-confirming products during the production process handling procedure
5-00174	新物料试机方案管理规程 Management Procedure for New Material Trial Plan
5-00062-01	供应商的质量管理 Quality Management of Suppliers

2.相关记录Related Records

记录代号Code	源文件代号Reference Number of Source Document	记录名称 Name of Record
5055	5-00060	物料供应商前期筛选表Primary Screening of Materials Suppliers Record
5101	5-00060	物料供应商形式审查表The Form Inspection Sheet of Material Supplier
5100	5-00060	物料小试评价表The Evaluation Form of Lab-scale Test of Materials
5441	5-00060	物料最小批量试用评价表The Evaluation Form of Minimum Lot Size Trial of Materials
5442	5-00060	物料正常批量试用评价表The Evaluation Form of Normal Batch Trial of Materials
5443	5-00060	合格物料供应商证书The Certificate of Qualified Material Supplier
5810	5-00060	合格物料供应商名单The Qualified Material Suppliers List
5121	5-00068	不合格品处理单The Nonconforming Product Processing Form
5446	5-00062	物料供应商资格终止通知单The Qualification Termination Notice of The Material Supplier
5815	5-00062	供应商年度审计计划表The Supply Annual Auditing Plan
5448	5-00062	供应商临时性审计计划表The Supply Temporary Auditing Plan
5449	5-00062	供应商月度审计计划表The Supply Monthly Auditing Plan
5812	5-00062	物料供应商定期评估表The Material Supplier Regular Evaluates Tables
5707	5-00062	供应商年度综合评估表The Annual Comprehensive Assessment of Material Supplier Tables
5813	5-00062	物料供应商动态维护通知表The Notice of The Material Suppliers Dynamic Maintenance
5814	5-00060	物料试用方案Material Trial Plan
5103	5-00060	中药制剂原料供应商基础信息调查表The Fundamental Information Questionnaire of the Origin of Traditional Chinese Medicine Suppliers
5105	5-00060	化学药品制剂原料药供应商基础信息调查表The Fundamental Information Questionnaire of Chemical Raw Materials Suppliers
5445	5-00060	辅料供应商基础信息调查表The Fundamental Information Questionnaire of Excipient Suppliers
5106	5-00060	包装材料供应商基础信息调查表The Fundamental Information Questionnaire of Packaging Material Suppliers
5447	5-00060	医疗用品供应商基础信息调查表The Fundamental Information Questionnaire of Medical Material Suppliers
5137	5-00060	消毒剂、清洁剂供应商基础信息调查表The Fundamental Information Questionnaire of Detergents and Disinfectants Suppliers
5138	5-00060	直接接触药品的气体供应商基础信息调查表The Fundamental Information Questionnaire of Directly Contact With Drugs’ Gas Suppliers
5139	5-00060	辅助物料供应商基础信息调查表The Fundamental Information Questionnaire of Supplemental Material Suppliers
50033	5-00062	供应商物料信息变更通知The Applier Material Change Notice
50069	5-00062	供应商审计延期申请表Application Form for Supplier Audit Extension
50082	5-00062	中药材及中药饮片产地清单The List of Origin of Traditional Chinese Medicine and Traditional Chinese Crude Medicine
50113	5-00060	新物料质量评估表The New Materials Evaluation Record

八．附录Appendix

附录一：形式审查内容

Appendix1:The Contents of Formal Examination

物料类别	供应商	基本形式审查内容
必报资料	选报资料
化学制剂生产用原料药	国产原料药生产商	《营业执照》副本、《组织机构代码证》、《药品生产许可证》副本及变更记载、《药品GMP证书》、原料药生产批件、质量标准、检验报告、产品工艺流程图、合作单位药包材注册证、销售人员法人授权委托书和身份证明。	公司基本情况简介、公司组织及机构图、主要生产设备及检验仪器一览表、质量体系自我评估、生产车间工艺布局平面图、厂区及仓库平面图、生产质量管理文件目录、质量管理体系认证证书。
国产原料药经销商或代理商	《营业执照》副本、《组织机构代码证》、《药品经营许可证》、《药品经营质量管理规范认证证书》、质量标准、检验报告、生产商的相关资料、生产商的代理或经销证明、销售人员法人授权委托书和身份证明。	公司基本情况简介、公司组织及机构图、厂区及仓库平面图、质量管理文件目录。
进口原料药经销商或代理商	《营业执照》副本、《组织机构代码证》、《药品经营许可证》、《药品经营质量管理规范认证证书》、进口药品注册批件、进口药品注册质量标准、口检报告、生产商的代理或经销证明、销售人员法人授权委托书和身份证明。	公司基本情况简介、公司组织及机构图、厂区及仓库平面图、质量管理文件目录。
进口麻醉药品、精神药品经销商或代理商	《营业执照》副本、《组织机构代码证》、《药品经营许可证》、《药品经营质量管理规范认证证书》、进口药品注册证批件、麻醉药品、精神药品的《进口准许证》、进口药品注册质量标准、检验报告、生产商的代理或经销证明、销售人员法人授权委托书和身份证明。	公司基本情况简介、公司组织及机构图、厂区及仓库平面图、质量管理文件目录。
属于新品研发联合申报工艺的原料药生产商	《营业执照》副本、《组织机构代码证》、《药品生产许可证》副本及变更记载、新品研发联合申报合同书、拟报批质量标准。	公司基本情况简介、公司组织及机构图、主要生产设备、检验仪器一览表、质量体系自我评估、生产车间工艺布局平面图、厂区及仓库平面图、生产质量管理文件目录、质量管理体系认证证书。
辅料	国产药用级辅料生产商	《营业执照》副本、《组织机构代码证》、《药品生产许可证》副本及变更记载、药品注册批件或生产批复、《GMP证书》（适用于经过GMP认证的生产商），质量标准、检验报告、产品工艺流程图、合作单位药包材注册证、销售人员法人委托证明及身份证明。	公司基本情况简介、公司组织及机构图、主要生产设备及检验仪器一览表、质量体系自我评估、生产车间工艺布局平面图、厂区及仓库平面图、生产质量管理文件目录。
国产药用级辅料经销商或代理商	《营业执照》副本、《组织机构代码证》、《药品经营许可证》及变更记载、《药品经营质量管理规范认证证书》、质量标准、检验报告、生产商相关资料、代理证明、销售人员法人委托证明及身份证明。	公司基本情况简介、公司组织及机构图、厂区及仓库平面图、质量管理文件目录。
进口药用级辅料经销商或代理商	《营业执照》副本、《组织机构代码证》、进口药品注册批件、进口药品注册质量标准、口检报告、生产商的代理或经销证明、销售人员法人授权委托书和身份证明。	《药品经营许可证》、《药品经营质量管理规范认证证书》、公司基本情况简介、公司组织及机构图、厂区及仓库平面图、质量管理文件目录。
进口非药用级辅料经销商或代理商	《营业执照》副本、《组织机构代码证》、质量标准、口检报告、生产商的代理或经销证明、销售人员法人授权委托书和身份证明。	公司基本情况简介、公司组织及机构图、厂区及仓库平面图、质量管理文件目录。
食品添加剂生产商	《营业执照》副本、《组织机构代码证》、《食品添加剂生产许可证》副本（或《全国工业产品生产许可证》副本、《食品卫生许可证》副本）、质量标准、检验报告。	公司基本情况简介、公司组织及机构图、厂区及仓库平面图、生产质量管理文件目录。
食品添加剂经销商	《营业执照》副本、《组织机构代码证》、《食品流通许可证》副本、质量标准、检验报告、生产商相关资料。	公司基本情况简介、公司组织及机构图、厂区及仓库平面图。
化学试剂生产商	《营业执照》副本、《组织机构代码证》、《工业产品生产许可证》或《安全生产许可证》（适用于所供物料中有危化品的生产商）、《非药品类易制毒化学品生产许可证》（适用于所供物料中有非药品类易制毒化学品的生产商）、质量标准、检验报告。	公司基本情况简介、公司组织及机构图、生产质量管理文件目录、消防环保合格证明、其他各项管理体系认证证书。
化学试剂经销商	《营业执照》副本、《组织机构代码证》、《危化品经营许可证》（涉及危化品的）、《非药品类易制毒化学品经营备案证明》（涉及非药品类易制毒化学品的）、质量标准、检验报告、生产商相关资料（危化品、非药品类易制毒化学品等特殊物料的经销商提供）。	公司基本情况简介、公司组织及机构图、消防环保合格证明。
与药品直接接触的内包装材料	国产内包装材料生产商	《营业执照》副本、《组织机构代码证》、《药品包装材料和容器注册证》、《印刷经营许可证》（仅涉及有文字印刷的内包材）、质量标准、检验报告、产品工艺流程图、销售人员法人委托证明及身份证明、上级环境测试检测报告（适用于最终进行微生物控制的产品）。	公司基本情况简介、公司组织机构图、生产车间平面图、厂区及仓库平面图、生产质量管理文件目录、主要生产设备检验仪器一览表。
进口内包装材料经销商或代理商	《营业执照》副本、《组织机构代码证》、《进口药包材注册证》、进口药包材注册质量标准、检验报告、销售人员法人委托证明及身份证明。	公司基本情况简介、公司组织机构图、厂区及仓库平面图。
中药材、中药饮片、中药提取物	中药材、中药饮片经销商	《营业执照》副本、《组织机构代码证》、《药品经营许可证》含变更记载、《药品经营质量管理规范认证证书》、公司质量负责人的在有效期范围内的执业中药师注册证或相关的重要性专业技术职称、销售人员法人授权委托书及身份证明、中药饮片经销商需提供所供中药饮片的质量标准及检验报告。	公司基本情况简介、公司组织机构图、厂区及仓库平面图。
中药材产地合作社、中药材产地种植公司	《营业执照》副本、《组织机构代码证》、销售人员法人授权委托书及身份证明。	合作社基本情况简介、合作社人员机构图、仓库布局平面简图
中药饮片生产商	《营业执照》副本、《组织机构代码证》、《药品生产许可证》及《GMP证书》、销售人员法人委托证明及身份证明、所供中药饮片的质量标准及检验报告。	公司基本情况简介、公司组织机构图、生产质量管理文件目录。
中药提取物生产商	《营业执照》副本、《组织机构代码证》、《药品生产许可证》副本及变更记载、《GMP证书》、药品生产批件（若有，必须提供）、国家药品标准、检验报告、工艺流程图、合作单位药包材注册证、销售人员法人委托证书及身份证明。	公司基本情况简介、公司组织机构图、生产质量管理文件目录、主要生产设备检测仪器一览表。
辅助物料	消毒剂	《营业执照》副本、《组织机构代码证》、《卫生许可证》或生产批件、消毒效果验证报告、质量标准、检验报告、生产商给经销商的代理证明（经销商提供）、销售人员法人委托证明及身份证明。	公司基本情况简介、主要生产设备、检验仪器一览表 、主要生产、质量管理文件目录、质量体系自我评估。
清洁剂	《营业执照》副本、《组织机构代码证》、质量标准。
医疗器械	《营业执照》副本、《组织机构代码证》、《医疗器械生产公司许可证》、《医疗器械注册证》、质量标准、检验报告、销售人员法人委托证明及身份证明、生产商给经销商的代理证明（经销商提供）、生产商相关资料（经销商提供）。	/
一次性手套、口罩	《营业执照》副本、《组织机构代码证》、《卫生许可证》质量标准、生产商给经销商的代理证明（经销商提供）、生产商相关资料（经销商提供）。	/
与药品直接接触的气体	《营业执照》副本、《组织机构代码证》、《安全生产许可证》（适用于危化品）或《全国工业产品生产许可证》、《中华人民共和国特种设备检验检测机构核准证》（若为委托检测，需提供委托协议及受托方的此证）、《气瓶充装许可证》（瓶装气体需提供）、质量标准、销售人员法人委托证明及身份证明、生产商给经销商的代理证明（经销商提供）、生产商相关资料（经销商提供）。	/
其他辅助物料	《营业执照》副本、《组织机构代码证》、物料行业准入所需的各类证书、质量标准。	物料有效性验证报告、生产商给经销商的代理证明（经销商提供）、生产商相关资料（经销商提供）。
印刷性外包装材料、标签和说明书生产商	《营业执照》副本、《组织机构代码证》、《印刷经营许可证》、商品条形码资格证明（仅涉及有商品条形码的印刷性外包装材料、标签和说明书）、质量标准、检验报告、销售人员法人委托证明及身份证明。	公司基本情况简介、公司组织机构图、生产质量管理文件目录。
非印刷性包装材料及附加物（如吸管、遮光材料、吸塑插盘、垫片、玻璃纸等）生产商	《营业执照》副本、《组织机构代码证》、质量标准、检验报告。	/
①以上所有检验报告若有法定部门检验报告的必须提供法定部门检验报告 ②对于E类物料，供应商管理员查询相关物料行业法规准入制度，并在《物料供应商基础信息调查表》中明确需提供的资质证明材料附件。 ③合格标准 －对于具有《营业执照》、《组织机构代码证》、《药品生产许可证》或《药品经营许可证》药品注册批件、或进口药品注册批件的公司，供应商管理员应在国家或省食品药品监督管理局、工商行政管理局等网站上进行核对和确认，应真实、准确无误，如有差异，需提供原发证机关出具的有效证明函，否则视为不具备资质不予受理，供应商管理员将材料退生产供应部。 －所有证书均应在有效期内，生产或经销的范围包括所选择物料。 －《营业执照》及《组织机构代码证》应提供最近一次年检的证件。 －以上所有证件如有变更记载项目，应一并提供。 －药品注册批件、进口药品注册批件或药用包装材料和容器注册证如已过期，应有SFDA核发的再注册受理通知书。 －质量标准如实行《中国药典》、YBB或GB标准的，由供应商提供公司标准，并在基础信息调查表中予以备注说明公司标准的制定依据。 －所有材料均提供复印件，字迹清晰，内容完整。每页材料复印件均需加盖供应商公司公章，盖章处不得掩盖关键信息，影响辨认和读取。

附录二：供应商选择简要流程图Appendix2:The Supplier Selection Flowchart

九．变更记载Change Record

编号 Code	生效日期 Effective Date	本次变更原因、依据及详细变更内容 Reasons ,basis and detail for these changes
5-003-01	2003年1月1日	首版文件 New document.
5-00060-02	2004年7月1日	1. 公司更名，采用新版格式和编号。1.Corporation is renamed, new format and code are introduced 2. 将物料供应商质量审计程序从此程序中分开。 完善物料供应商的选择与质量管理，增加了新物料试验评价表、供应商产品质量评价表、物料临时入库通知单（正本、副本）3种记录。 2. Dividing the material supplier quality auditing procedure from this procedure.  Having improved the selection and quality control of the materials and added three records of new material trial evaluation form, supplier product quality evaluation form, material temporary warehousing notice(original ,transcript).
5-00060-03	2006年8月1日	新物料试验评价表增加QA评价结论[评价表上的编号变为 02（SOP5-00060）]。The material trial  evaluation form have been added the evaluation conclusion[the code number changed to 02（SOP5-00060 ） ]
5-00060-04	2007年10月1日	完善物料供应商的选择与质量管理流程，优化了新物料试验评价表[评价表上的版本号升级为 03（SOP5-00060）]。Having improved the process of the selection and quality control, and optimized the new material trial evaluation form [the edition number upgraded to 03(SOP5-00060)].
5-00060-05	2011年08月15日	1. 增加物料供应商的前期筛选及临时性、月度审计计划。Having added the primary screening of material suppliers, temporary, monthly audit plan. 2. 改变供应商的分类方式，原来只按照I类和Ⅱ进行管理，现在分为合格供应商和临时性供应商，按风险级别分为A、B、C、D、E类，并对各类物料的管理进行了明确的规定，合格物料入库不需开具临时入库单。 3. Having changed way of sorting the suppliers. The original types are in accordance with type I and typeⅡ, but now are divided into qualified suppliers and temporary supplier, ranking class A, B, C, D and E, and the management of all kinds of materials are clearly regulated and the qualified materials do not need to issue temporary storage warehouse receipts. 4. 新物料试用评价分小试、最小批量试用、正常生产批量试用，且新物料试用评价的流程发生改变，小试方案需经QA主管审核批准，最小批量及正常批量试用方案需经质量管理部长审核批准。方案批准后流转至生产供应部采购物料，仓库凭新物料试用评价表准许物料入库。 5. The new material trial evaluation is divided into lab-scale test, minimum batch trial and normal production batch trial, and the process new material trial evaluation has been change. The lab-scale test plan should be audited and approved by QA manager and the minimum batch and normal batch trial plan needs the approval of the minister of Quality Management Dept. Being approved, the plans should be transferred into Material Supply Dept. for purchasing materials, with new material trial evaluation sheet, the warehouse allowing materials into storage warehouse. 6. 增加对不同类别物料的定期评估要求。 7. Having added the demands for different types of material regular evaluation. 8. 不合格物料判定标准变化。A change of the Decision criteria of unqualified materials. 9. 增加合格供应商证书、物料供应商资格终止、对物料供应商的定期评估及年度评估、供应商动态维护通知。Having added terms of the certificate of qualified suppliers, terminating qualification of material suppliers, regular evaluation and annual assessment for material suppliers, dynamic
5-00060-06 5-00060-06	2011年9月24日 2011年9月24日	1.因物料试用评价表中有QA主管和质量管理部长对试用方案的审核批准要求，故将《物料试用方案5814》中QA主管和质量管理部长审核删去。Due to approval requirements for trial from QA manager and the minister of Quality Management Dept. have existed in the material trial evaluation form, the term of auditing of QA manager and the minister of Quality Management Dept. in “the material trial plan 5814” will be deleted. 2.删去物料的年度回顾要求，与物料定期质量回顾结合。Delete the material requirement of annual review and   material quality review on a regular basis is added. 3.将D类中“非印刷性包装材料”调整为“非印刷性外包装材料”change materials in class D "non printed packaging material" for "non printed inner packaging material". 4.B类物料供应商审计周期由“3年/次”该为“5年/次”，但其中合成原料药起始物质及中药材、中药饮片审计周期参照C类物料审计周期执行。Change material supplier audit cycle of materials Class B from "one time/three years" to the "one time/ five years", but the audit cycle of the API starting materials, Chinese herbal medicine, TCM refers to the audit cycle of materials class C for performing. 5.增加“3.3.5.”若因特殊情况不能及时完成审计计划的，由QA主管在月度审计计划编制时提出延期申请并经过批准，延期时间不得超过6个月。Add the term of “3.3.5.” If not completing audit plan in time due to special circumstances, QA supervisor put forward an extension application and pass an approval when the monthly audit planning is established and the extension shall not exceed six months. 6.将化工原料及吸管调整为C类物料。Adjust the chemical raw materials and straw for the C class materials. 7.对各类物料基础信息调查表中必报资料进行修改，基础信息调查表版本升级。Modify basic information questionnaires of all kinds of materials essential reported data and upgrade the edition of the questionnaires. 8. 将A类物料的评估由“每半年一次”改为“每一年一次”。The evaluation of materials class A is changed for "once every half A year" instead of "once every year”. 9.对物料定期质量评估表进行升级，将第2.对物料检测数据进行趋势性分析改为对所有检验不合格及发生质量信息反馈的批次进行统计、分析。Upgrade the form of material quality assessment on a regular basis and change the term of “material testing data for trend analysis” for “batches of unqualified inspection and quality information feedback for statistics and analysis”. 10.增加物料定期评估后续采取措施的标准规定： Add prescribed standards of adopting follow-up measures for material regular assessment. －继续使用（A类物料供货批次≤10批/年，供货质量≤1次反馈或检验不合格；供货批次≥11批/年的，供货质量≤1次反馈或检验不合格/10批统计。B、C类物料供货批次≤10批/年，供货质量≤2次反馈或检验不合格；供货批次≥11批/年的，供货质量≤2次反馈或检验不合格/10批统计）Continuing to use (the availability batches of material class A is no more than ten batches every year, the quality of material is feedback or unqualified and it happened no more than once; The availability batches is more than eleven batches every year, the quality of material is feedback or unqualified and it happened no more than once according to statistics every 10 batches. the availability batches of material class B,C are no more than ten batches every year, the quality of material is feedback or unqualified and it happened no more than twice; the availability batches are more than eleven batches every year, the quality of material is feedback or unqualified and it happened no more than twice according to statistics every 10 batches) －同步整改（A类物料供货批次≤10批/年，供货质量达2～3次反馈或检验不合格；供货批次≥11批/年的，供货质量达2～3次反馈或检验不合格/10批统计。B、C类物料供货批次≤10批/年，供货质量达3～4次反馈或检验不合格；供货批次≥11批/年的，供货质量达3～4次反馈或检验不合格/10批统计）Synchronous rectification (the availability batches of material class A is no more than ten batches every year, the quality of material is feedback or unqualified and it happened twice or three times; The availability batches is more than eleven batches every year, the quality of material is feedback or unqualified and it happened twice or three times according to statistics every 10 batches. the availability batches of material class B,C are no more than ten batches every year, the quality of material is feedback or unqualified and it happened twice or three times; the availability batches are more than eleven batches every year, the quality of material is feedback or unqualified and it happened twice or three times according to statistics every 10 batches) －整改合格后试用，同步安排现场审计（A类物料供货批次≤10批/年，供货质量达4次反馈或检验不合格；供货批次≥11批/年的，供货质量达4次反馈或检验不合格/10批统计。B、C类物料供货批次≤10批/年，供货质量达5次反馈或检验不合格；供货批次≥11批/年的，供货质量达5次反馈或检验不合格/10批统计）Using after passing the rectification and arranging on-site audit synchronously ( the availability batches of material class A is no more than ten batches every year, the quality of material is feedback or unqualified and it happened four times; The availability batches is more than eleven batches every year, the quality of material is feedback or unqualified and it happened four times according to statistics every 10 batches. the availability batches of material class B,C are no more than ten batches every year, the quality of material is feedback or unqualified and it happened five times; the availability batches are more than eleven batches every year, the quality of material is feedback or unqualified and it happened five times according to statistics every 10 batches) －终止资格（A类物料供货批次≤10批/年，供货质量≥5次反馈或检验不合格；供货批次≥11批/年的，供货质量≥5次反馈或检验不合格/10批统计。B、C类物料供货批次≤10批/年，供货质量达6次反馈或检验不合格；供货批次≥11批/年的，供货质量达6次反馈或检验不合格/10批统计）。 Termination of eligibility ( the availability batches of material class A is no more than ten batches every year, the quality of material is feedback or unqualified and it happened more than five times; the availability batches is more than eleven batches every year, the quality of material is feedback or unqualified and it happened more than five times according to statistics every 10 batches. the availability batches of material class B,C are no more than ten batches every year, the quality of material is feedback or unqualified and it happened six times; the availability batches are more than eleven batches every year, the quality of material is feedback or unqualified and it happened six times according to statistics every 10 batches) 11.化工原料的审计由“首次审计”改为“以形式审查为主，根据物料使用情况进行现场审计”、E类物料的审计由“首次审计”改为“根据质量管理部最终意见决定是否需要进行首次现场审计；使用过程中根据物料使用情况进行现场审计，按临时性审计计划管理。” Change the audit of chemical raw materials from“the first time audit” to “giving priority to form examination and carrying out an on-site audit according to the use of materials ”;for auditing of materials class E, change ’”the first time audit” to “determining whether carrying out a first on-site audit or not according to the final reviews from Quality Management Dept.; the process of use shall carrying out an on-site audit according to the use of materials  and is managed by the temporary auditing plan”.
5-00060-07	2012年11月25日	11.将形式审查不合格意见修订为“若形式审查不合格，则拒绝增加，对于部分急用但形式审查资料不能及时提供完全的情况（物料前期筛选表上要求的基础形式审查资料必须已提供完全），可限期整改。” Revise opinions for the unqualified supplier of form examination to “if the form examination of the supplier is unqualified, decline it; for part situation of  materials being urgent use but not providing form examination data in time(the basic form examination data in the primary screening form have been provided ) , make it rectify in a limit time ”. 2.对A、B、C类物料的试用评价要求进行变更，原为“A、B类：小试至少应开展1批，合格后可进入最小批量试用阶段；对无菌制剂用原料药及辅料、非无菌制剂原料药、无菌制剂直接接触药品的内包装材料，应至少开展3批最小批量试用评价（与工艺验证同步进行），生产的制剂应开展加速和长期稳定性考察。如需办理供应商变更补充申请的，应按照国家食品药品监督管理局《药品注册管理办法》和省局相关文件要求办理供应商变更补充申请；非无菌制剂大宗辅料（占制剂处方量的30%以上）应开展3批试用评价，并进行连续三批工艺验证，可同步开展长期和加速稳定性考察。C类：可不进行小试，可直接开展最小批量试用或正常批量试用，试用一般不少于3个制剂批次”，变更后见2.5.2中 “小试要求”、“最小批量试用要求”、“正常批量试用要求”。Change requirements of trial evaluation of materials class A, B and C. The former provisions are in the following.  “Materials class A and B:not less than one batch in the lab-scale test, entering into the minimum batch trial after a qualified lab-scale test; for Starting materials for sterile products, row materials for non- sterile products, Immediate packaging materials oppressed to non-sterile products , the materials should be carried out for trial evaluation of 3 minimum batches trial (trial evaluation can be carried out simultaneously with the process validation) and production preparations should carry out accelerated and long term stability test; if there is a need for the supplier change supplemental application the related departments should process supplemental applying  according to "drug registration management approach" of SFDA and the provincial pharmaceutical sector related documentation requirements . Staple excipients (over 30% prescribed dose of preparations ) for sterile products  should be carried out for trial evaluation and process validation of 3 minimum batches trial (trial evaluation can be carried out simultaneously with the process validation) and production preparations should carry out accelerated and long term stability test. Materials class C: not carrying out lab-scale-test and the minimum or normal volume trial can be directly carried out and the trial not less than 3 batches”. After the change, it can refer to the terms of “2.5.2. “. 3. B类物料评价的评估意见中增加“不需开展试用工作，形式审查、现场审计合格后正常使用”“其它等”。The assessment opinions of materials class B add “not carry out trial work, being used after the form examination and on-site audit are qualified”, “others”. 4.增加试用物料的放行要求。Add release requirements for trial materials. 5.试用产品的取样人员由“QA”变更为“经授权的人员”；对于QC正常稳定性考察发现有异常的品种，“小试后第一批应进行重点留样观察”修订为“试用评价的产品应进行稳定性考察。” The sampling staffs changed from “QA” to “the authorized staffs”; For QC observing abnormal product in the normal stability study, revise “the first batch should be focused on sample observation after the lab-scale test” to “products of trial evaluation should carry out stability study”. 6.删除《合格供应商转临时性供应商通知单5444》。 Delete the sheet 7.对质量协议的签署进行修订，原为“生产供应部签署采购合同前，应具有质量管理部下发的已生效的质量协议，在新物料试用评价方案经质量管理部长批准后十个工作日内完成质量协议的签订”，更改后见“3.2质量协议签署相关规定”。Revise the signing of quality agreement. The original is “before Material Supply Dept. signs the contract, a quality agreement issued by Quality Management Dept. and came into force is a must and completing signing of the quality agreement in ten work days after the new material trial evaluation plan is approved by the minister of Quality Management Dept.”, and is changed for the current referring to “3.2.Quality agreement rules”. 8.对不能完成审计计划的处理方式进行修订，原为“若因特殊情况不能完成审计计划的，由QA主管在月度审计计划编制时提出延期申请并经批准，延期时间不得超过6个月”，更改后具体见“3.3.4.7中审计周期相关规定”。 8.Revising the handling ways of not completing the audit plan, the former is “if it can’t complete the audit plan for the special cases, the QA supervisor raises extension request when making the monthly audit plan and approves it, the deferred time is less than six months”, the changed details refers to the related stipulation of “3.3.4.7”. 9.删除基础信息调查表中的“扬子江药质审字（）第（）号”，基础信息调查表版本升级,同时根据相关法规要求对基础信息调查表中必报资料进行修订。 9. Deleting “Yangtze river pharmaceutical review word () number ()”, the versions of basic information questionnaire table is upgraded as well as revising the necessary report material of basic information questionnaire table according to the related stipulation. 10.增加每季度中药材及中药饮片产地清单的下发管理。 10. Adding the administration of the list of origin of traditional Chinese medicine and traditional Chinese crude medicine every quarter. 11.增加《物料供应商信息变更通知50033》。 11. Adding “The Applier Material Change Notice 50033” 12.将供应商类别分为“合格供应商”、“待评价供应商”、“不合格供应商”、“再评价供应商”进行管理。 12. Administrating the classes of suppliers which are divided to “the qualified suppliers”, “the testing suppliers”, “the unqualified suppliers” and “the reappraisal suppliers”. 13.将供应商动态维护周期由一个月更改一个季度。 13. Revising the dynamic maintenance of supplier cycle and a month changes over from a quarter. 14.增加对合格供应商新增物料的审计规定。 14. Adding the audit stipulation of new materials of the qualified suppliers. 15.将原C类中的食品添加剂升级为B类物料。 15. Upgrading the food additives of materials class C to materials class B. 16.B类物料定期评估周期由“1年”变更为“2年”，B类物料中的中药材、中药饮片审计周期由“参照C类物料进行首次审计”修订为“1次/5年”。 16. Revising the regular assessment cycle of materials class B, a year changes over to two years, Revising  the origin of traditional Chinese medicine and traditional Chinese crude medicine audit cycle of materials class B ,the cycle changed over to once every five years according to materials class C. 17.增加“对于进口物料及部分不具备现场审计条件的国产物料(A类物料除外)，可对该物料经销商或代理商进行现场审计，主要对仓储、运输等条件进行考察。” 17. Adding imported materials or partial domestic materials (class A not included)，which could not provided with an on- site audit, instead we should make an on- site audit from the material dealer or agent, investigating conditions of storage and transportation. 18.增加“流转《物料供应商前期筛选表5055》，应将供应商的基础形式审查资质材料附入，具体要求见《物料供应商前期筛选表5055》。”的规定，《物料供应商前期筛选表5055》版本升级。 18. Adding when the record flow from person to person, quality review materials of foundation form provided by suppliers should be attached to, and concrete request refers to “Primary Screening of Materials Suppliers Record5055”,upgrading the versions of “Primary Screening of Materials Suppliers Record5055” 19.将SOP格式修订为表格形式。 19. The format of SOP changes over to the table. 20.将供应商年度综合评估中现场审计评分权重由5分改为10分。 20. The weights of on-site audit of the annual comprehensive assessment of supplier are changed over to 10 points. 21.增加“对于正式投入使用前需进行现场审计的物料供应商，原则上应审计合格后相关物料方可正式投入使用，特殊情况下，可在正式投入使用后6个月内进行现场质量审计，但需经质量管理部长批准。正式投入使用后6个月内不能完成审计的，由QA主管或生产供应部采购员填写《供应商审计延期申请表50069》，并经质量管理部部长批准（因质量管理部人员安排的，由QA主管提出；因供应商问题的，如不具备审计条件，由生产供应部采购员提出）”的规定。 21. Adding for material suppliers which need to be conducted an on-site audit, in principle, materials will not be officially put into use until the on-site audit is qualified .And in some particular circumstances, the materials can be put into use and be conducted an on-site audit in 6 months, but these cases should be approved be the minister of Quality Management Dept.. If within 6months, the audit cannot be completed, the QA manager or the purchasers should fill out the form “The Supplier Audit Extension Application Form 50069” for extension, and then transfer the form to the minister of Quality Management Dept. for approval (If the extension is arranged by personnel of Quality Management Dept., it should be put forward by QA manager; 22.增加《供应商审计延期申请表50069》。 22. Adding “the Supplier audit extension application form 50069”. 23.《物料供应商资格形式审查表5101》版本升级。 23 The versions of “The Form Inspection Sheet of Material Supplier 5101” are upgraded.
5-00060-09	2013年7月18日	1. 在物料分类的E类（辅助物料）中增加“医用包装用Tyvek/聚乙烯洁净袋”。 1. In the materials class E (auxiliary materials) adds “Tyvek/ polyethylene clean bags used for medical packaging” 2. 在2.4.2中对B、C、D、E类物料的供应商审计报告的管理增加“经质量管理部长确认批准后作为审计依据”。 2. .In the 2.4.2 adding “the copies being approved by the minister of Quality Management Dept. as the auditing basis.” for the administration of suppliers audit report of materials class B , C, D, E. 3. 在《物料供应商前期筛选表5055》的中增加“原料药生产用原料”的供应商类别，记录升级为03版。 3. Adding the suppliers’ class of initial materials of row materials in the “Primary Screening of Materials Suppliers Record5055”, the version is upgraded version 03. 4. 在《物料供应商定期评估表5812》中删除“后续是否再次出现”，记录升级为04版。 4. “ The Material Supplier Regular Evaluates Tables, 5812”
5-00060-10	/	1.责任者中QC的职责增加“对前期筛选阶段的A类、B类物料中的非无菌制剂辅料的小样进行检测，在评估表中填写检测结果”；增加“QA：对前期筛选阶段的A类、B类物料中的非无菌制剂辅料的小样检测数据与以往检测数据进行对比，在评估表中填写对比结果。” the duty of QC adding “inspect the excipient samples of non sterile preparation of the preliminary screening class-A、class-B materials, then to fill in on the assessment results. Adding “QA: contrast inspection data of the excipient samples of non sterile preparation of the preliminary screening class-A、class-B materials with historical data, then fill the comparing results in the assessment table.” 2.2.1.2.增加在前期筛选阶段对于A类、B类物料中的非无菌制剂辅料进行质量评估的内容； 2.1.2.Adding the contents of inspection data of the excipient samples of quality assessment for class-A、class-B materials 3.修改3.1.2项下对于药物研究院拟报批工艺报批确定的供应商的规定，增加“在获得生产批件后正式投入生产前对相应供应商进行供应商现场审计”的描述； Revising the projects of 3.1.2 for the identified suppliers whose materials used for process approval are approved by drug research and development dept,  adding the description of “should make an on-site audit to corresponding suppliers between the time after production approval and before the materials being put into use.” 4.增加3.4.2.3评分细则项的相关内容； Adding the related contents of the scoring rules in the 3.4.2.3 5. 3.4.2.4项中增加“质量管理部在3月10日前完成综合分析和评价，并将《物料供应商年度综合评估表5707》交质量管理部部长审核批准。” 3.4.2.4 the project adds “the Quality Control Unit completes it before March 10 and submits “The Annual Comprehensive Assessment of Material Supplier Tables, 5707”, finally the minster of the Quality Control Unit reviews and approves it.” 6.增加《新物料质量评估表50113》。 Adding “The New Materials Evaluation Record50113” 7.“附录一：形式审查内容”中药材、中药饮片经销商、中药饮片生产商的必报资料增加中药饮片经销商需提供所供中药饮片的质量标准及检验报告、所供中药饮片的质量标准及检验报告，并升级《中药制剂原料供应商基础信息调查表5103》为06版。 In the”Appendix1: The contents of former audit”, the suppliers’ necessary materials of the origin of traditional Chinese medicine and traditional Chinese crude medicine add that the suppliers of the origin of traditional Chinese crude medicine provide the quality standard and inspection report, the version of “The Fundamental Information Questionnaire of the Origin of Traditional Chinese Medicine Suppliers, 5103” is upgraded version 06.
5-00060-11	/	1.相关定义中新增待评价物料供应商；删除原料药起始物料的定义 Add “material suppliers awaiting assessment” in the relevant definitions; Delete “API starting materials”. 2.物料分类，新增中药制剂中的原料；化学试剂更改为制剂中化学试剂；新增E类物料验证用无纺棉；删除“原料药生产用原料药起始物料”、“原料药生产用原料中的化工原料” Material classification: Add the item of raw materials of traditional Chinese medicine in material classification; change “chemical reagents” to “chemical reagents for preparation”; add cotton used in validation in  E class materials；Delete “Starting materials of API”,“Chemical materials for API”. 3. 2.3形式审查，新增供应商生产供应部需一周内流转至质管部供应商管理员处进行审核的要求。 Add in 2.3 Form inspection: when new suppliers are added, Material Supply Dept should sent the related documents to  the supplier administrator within one week Quality Management Dept.. 4. 2.4现场审计增加“2.4.3.集团内的A类物料的供应商，必须在批量试用前/正式投入生产前现场审计。对于B、C、D类物料中需进行现场审计的供应商，原则上应审计合格后方可正式投入使用，特殊情况下，可在正式投入使用后6个月内进行现场质量审计，但需经质管部部长批准。”“2.4.4.不能按期完成审计的，由QA主管或生产供应部采购员填写《供应商审计延期 申请表50069》，并经质管部部长批准（因质管部人员安排的，由QA主管提出；因供应商问题的，如不具备审计条件，由生产供应部采购员提出）。” Add in 2.4“For suppliers of materials in Class A, on site audit must be carried out before trial use in bulk or formal production. For those suppliers of materials in Class B, C and D that need to be on-site audited, generally audit should be carried before formal production. In specific situations, on-site audit can be carried out in 6 months after formal production involving the materials. However, these cases should be approved be the minister of Quality Management Dept. ”“If on site audit cannot be completed as required, “Application Form for Supplier Audit Extension 50069” should be filled by QA supervisor or purchasers and approved by Manager of Quality Management Dept. (If the extension is due to the management in Quality Management Dept., it should be proposed by QA supervisor; if it is due to suppliers, it should be proposed by purchasers).” 5.优化B类物料中药材和中药饮片的试用评价流程。 For Class B materials: Optimize the trial evaluation process for the TCM and decoction pieces. 6.2.5.1.确定试用方案程序中，增加药物研究院注册组组长审核要求；并对《物料小试评价表5100》《物料最小批量试用评价表5441》《物料正常批量试用评价表5442》《物料试用方案5814》进行修改，《物料小试评价表5100》升级为05版，《物料最小批量试用评价表5441》升级为02版，《物料正常批量试用评价表5442》升级为02版，《物料试用方案5814》升级为03版。 Add in2.5.1: Trial plan should also be reviewed by the team leader of registration team in Drug Research and Development Dept. “The Evaluation Form of Lab-scale Test of Materials 5100” update to 05, “The Evaluation Form of Minimum Batch Trial of Materials 5441” update to 02, “The Evaluation Form of Normal Batch Trial of Materials 5442” update to 02, “Material Trial Plan 5814” update to 03. 7.2.8.供应商的批准A/B类物料批准的前提，增加按规定已进行备案或完成了供应商变更补充申请的受理通知书下发后。 Add in the premise for approval of the supplier for material Class A/B in 2.8.:“when the acceptance notice for filing or supplemental application of supplier change has been issued”. 8.删除“2.8.2”项目内容。Delete “2.8.2” 9.供应商批准相关管理规定中，增加物料供应商重要变更后，我公司执行变更控制的要求。Add in related regulations for supplier approval: when critical changes occurred in any materials, change control procedure should be conducted in our company.. 10.新增2.9.待评价物料供应商的新增程序及管理。 Add related regulations for material suppliers awaiting assessment in 2.9. 11.删除供应商管理的相关内容。 Delete the relevant contents of the Supplier Management. 12.增加“六.制定依据” Add item“6.Basis” 13.附录一：增加“中药材产地合作社、中药材产地种植公司”的形式审查内容，并升级《中药制剂原料供应商基础信息调查表5103》为07版。 Appendix 1：Add file inspection requirements for cooperatives and planting company of TCM, and upgrade “The Fundamental Information Questionnaire of the Origin of Traditional Chinese Medicine Suppliers, 5103” to version 07.

赞恩

这个文件看着好熟悉。。。。

孙艳红

文件很全面，不知能严格执行不？

chenjiao501

不适用于我们公司，想了解实际执行情况

wsh921

文件很全面

jyuanmei

文件确实很全面，学习了，谢谢分享