验证主计划(VMP)

验证总计划

Validation Master Plan

文件编号Protocol Number VMP-001

编写日期Preparation Date 2006.07

编写部门Preparation Department 质量管理部

保管部门Storage Department 质量管理部

浙江华海药业股份有限公司ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD

浙江华海药业股份有限公司

ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD

文件批准

Document Approval

下面签字者已阅读了该文件并同意该文件中描述的设施设备验证总计划。此外，签字人还认为，对于所涉及的设施设备，该文件中描述的程序，给出了充分的证据证实华海药业为验证及符合cGMP所付出的努力。

The undersigned have read and agree with the Facility Validation Master Plan as outlined in this document. Furthermore, the undersigned agree that the procedures outlined in this plan provide sufficient evidence of HUAHAI PHARMA’s dedication to validation and current Good Manufacturing Practices with respect to the facility described by this plan.

目录

Contents

一. 前言Preface (2)

二. 目的Purpose (4)

三. 定义Definition (5)

四. 范围Scope (14)

五. 验证理念 Validation Philosophy (18)

六. 组织与职责 Organization and Responsibilities (20)

七. 支持程序Support Procedure (22)

八. 工艺验证 Process Validation (26)

九. 返工Rework Procedure (27)

十. 包装验证Packaging Validation (27)

十一. 清洁验证 Cleaning Validation (30)

十二. 分析方法验证Test Method Validation (32)

十三. 设备验证Equipment Qualification (33)

十四. 公用系统Utilities (38)

十七. 验证文件要求Documentation (43)

十八. 变更记载及原因Revision History (45)

一. 前言Preface

浙江华海药业股份有限公司始创于1989 年1 月，主要从事原料药及制剂的研发、制造、销售及相关服务活动。制剂大楼于2001 年建成，建筑占地面积1.1 万平方米，建筑面积2.2 万平方米。口服固体制剂车间（包括片剂和硬胶囊剂）位于制剂大楼内。车间建筑面积3500 平方米,其中洁净区面积2000 平方米，按10 万级净化标准设计建造；仓贮面积3500 平方米；公用机房等辅助用房建筑面积3000 平方米。固体制剂车间年设计生产能力片剂10 亿片、胶囊2 亿粒，从造粒到包装整条生产线全套引进国际先进设备，现生产盐酸帕罗西汀片、厄贝沙坦片及抗艾滋病药物奈韦拉平片等5 个产品（7 个包装规格，见附件一）。

Zhejiang Huahai Pharmaceutical Co., Ltd., established in January 1989, is devoted to the development, production, distribution and relative services, of API and Preparation. The preparation building area is11,000m2, floor space is 22,000m2 and area was built in 2001. The oral solid finished dosage form workshop (including tablets and hard capsules) is located in the building. The floor space of the workshop is 3,500m2, clean room area is 2,000m2, and it was designed and constructed according to class100, 000. The area of the warehouse is 3,500m2 while the floor space for utility room and auxiliary room is 3,000m2. The annually capacity is: 1 billion tablets, and capsules 200 million. The workshops which house the imported production lines, now produce 5 products including Paroxetine Hydrochloride, Irbesartan Tablets and Nevirapine Tablets used for anti-AIDS (7 packing specifications, see appendix 1).

公司建立了完善的质量管理体系，厂房、设备等硬件设施按照cGMP要求设计和建造，物料、生产过程控制和销售均严格遵循cGMP 要求，确保产品质量。

The company has established: a quality assurance system. The facility and equipments were designed and constructed according to cGMPs. The control of material, production and sales also comply with the cGMPs, as well as the company’s own product quality assurance policies.