供应商审计管理规程

Standard Operating Procedure

标准操作规程 Page页码：1/9

Document Name: Vendor Policy

文件名称： 供应商审计管理规程

Document No.

文件编号 Version No.

版本号 Supercede No.

替代号 Executive Date

执行日期

A03 A02

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 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’ (AVL) 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 Standard Operating Procedure

标准操作规程 Page页码：2/9

Document Name: Vendor Policy

文件名称： 供应商审计管理规程

Document No.

文件编号 Version No.

版本号 Supercede No.

替代号 Executive Date

执行日期

A03 A02

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 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 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， Standard Operating Procedure

标准操作规程 Page页码：3/9

Document Name: Vendor Policy

文件名称： 供应商审计管理规程

Document No.

文件编号 Version No.

版本号 Supercede No.

替代号 Executive Date

执行日期

A03 A02

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。