供应商审计管理规程

Standard Operating Procedure

1. 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