Standard Operating Procedure1. Purpose目的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 vendors 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: 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’ (A VL) shall be maintained for Active Pharmaceutical Ingredients (API), excipients and packing materials. This shall be prepared 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 A VL/RM/01 for raw material (RM) and A VL/PM/01 for packing material (PM), where 01 indicates the Revision No. starting from 01.批准的供应商列表”（A VL）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A V/RM/01，A V/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 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）6.3.2 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, personnel & 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 soft 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 filled 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。
6.4.2 QA manager shall evaluate the filled questionnaire, if not satisfactory, 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 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 manufacturer 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, 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。