冷库设计确认

Design Qualification Protocol of Cold Storage Rooms

冷库设计确认方案

Table of Content

目录

1INTRODUCTION 概述 (3)

2RESPONSIBILITY 职责 (3)

3SYSTEM\EQUIPMENT DESCRIPTION 系统\设备描述 (3)

4PROCEDURE 程序 (4)

4.1Prerequisites for DQ DQ前提 (4)

4.2Table of Requirements 需求表 (4)

4.3DQ 设计确认 (4)

4.4Report 报告 (4)

5ABBREVIATIONS AND DEFINITIONS 缩写和定义 (5)

6Reference Documents 参考文件 (5)

7Change Log 修订日志 (6)

Appendix A Participant List 附录A 参会人员 (7)

Appendix B Design documentation and URS verification 附录B 设计文件和用户需求确认 (8)

Appendix C Table of Requirement 附录C 用户需求确认 (9)

Appendix D Deviation List 附录D 偏差列表 (15)

Appendix E Deviation Report附录E 偏差报告 (16)

1 INTRODUCTION 概述

The purpose of the protocol/report to describe and document the design qualification.

本方案\报告的目的是描述和记录设计确认。

The purpose of design qualification is to assess whether the proposed design of the facility/equipment is expected to be "fit for the intended use” of the facility/equipment and meet user and compliance requirements".

设计确认的目的是评估提出的设施/设备的设计是否如预期满足设施/设备的使用和符合性要求。

2RESPONSIBILITY 职责

It is the responsibility of engineering\process department to assure process requirements, equipment facilities and operation requirements are addressed in design documents.

工程\工艺部门的责任是确保工艺要求、设备设施和操作要求在设计文件中得到满足。

The engineering responsible approve this document on GMP compliance.

质量保证部负责审查本文件是否符合GMP要求。

The quality manager is responsible for approving this document to meet the requirements of the quality management system and GMP.

质量保证部负责批准本文件符合质量管理体系和GMP的要求。

3SYSTEM\EQUIPMENT DESCRIPTION 系统\设备描述

There are three cold storage rooms in the first floor .The cold storage rooms are used to keep the 2-8 ℃environment to keep the materials and products that are temperature sensitive.

一层3个拼装式冷藏库。冷藏室保持2-8摄氏度的环境，以保护对温度敏感的材料和产品。

The refrigeration system of the cold storage consists of a direct expansion indoor fan coil unit, a compressor located on the outdoor roof and a condenser located on the ceiling.

冷库的制冷系统由直接膨胀式的室内风机盘管单元，一个位于室外屋面的压缩机和一个位于吊顶的冷凝器组成。

Two cooling system (one is standby) shall be considered for each cold room.

每一个冷库应考虑两套制冷系统（一用一备）。

4PROCEDURE 程序

4.1Prerequisites for DQ DQ前提

User requirement specification and design specifications are approved.

用户需求和设计已批准。

4.2Table of Requirements 需求表

●Preparation of table of requirements. Fill in table of requirements with requirements from TS

准备需求表。在需求表中填入用户需求要求

●Enclose table of requirements for protocol as Appendix B

将需求表作为本方案的附录B

4.3DQ 设计确认

●DQ protocol is approved.

设计确认方案批准。

●Production responsible person calls in a design qualification meeting between production responsible

person, QA and system responsible (if relevant). Review the selected requirements and design documents to make sure that the requirements are reflected in the design documentation. All personnel involved need sign in participant list, Appendix A

生产负责人召集生产负责人、QA和系统负责人参加的设计确认会议。审核需求和设计文件确保设计文件中反映了需求。所有相关人员需在参加者名单(附录A)上签字

●Verify the approved URS and design documents relevant. Register the versions in Appendix B

验证批准的URS和相关设计文件。在附录B中登记版本

●Apply actions if the requirements are not implemented in the design. Actions to be applied are

documented in Deviation List (Appendix C)

如果需求在设计中未实施，应采取措施。采取的措施记录在偏差清单里(附录C)

●All the verification can be performed in e-form and then printed out, sign and date by the executor.

所有验证都可以通过电子表格进行，然后由执行人打印、签名和日期

4.4Report 报告

Apply the overall conclusion on the design qualification in the conclusion box when actions are fullfilled.

措施完成时，在结论栏写入设计确认的总结论。

The protocol section, the completed table of requirements and Action List, and the conclusion constitute the report.

设计确认的方案、完成的需求表和措施清单及结论组成报告。

Approve the report when the required actions are fulfilled and the conclusion is prepared.

当必需的措施完成且完成结论部分，批准报告。

5ABBREVIATIONS AND DEFINITIONS 缩写和定义

6Reference Documents 参考文件

?“Good Manufacturing Practice for Pharmaceutical Products”（2010 Version）

《药品生产质量管理规范》（2010年修订版）。

?Cold storage design code (GB50072-2010)

冷库设计规范（GB50072-2010）

?Code for construction and acceptance of field equipment, industrial pipe welding engineering (GB50236-2011)

现场设备、工业管道焊接工程及验收规范（GB50236-2011）

?Code for construction and acceptance of refrigeration and air separating equipment installation engineering (GB50274-2010)

制冷设备、空气分离设备安装工程施工及验收规范（GB50274-2010）

?Relative standards of EMEA and FDA cGMP

欧盟和美国相关cGMP标准

?Relative Standard of IEC (International Electro-technical Commission)

IEC（国际电工委员会）相关标准

?Other relative standard/regulation/code of local/national.

地方及国家相应的的其它规范、规定及标准

7 Change Log 修订日志

Appendix A Participant List 附录A 参会人员

Appendix B Design documentation and URS verification 附录B 设计文件和用户需求确认

Appendix C Table of Requirement 附录C 用户需求确认

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Appendix D Deviation List 附录D 偏差列表

Deviation List

偏差列表

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Appendix E Deviation Report附录E 偏差报告

Design Qualification Report of Cold Storage Rooms

冷库设计确认报告

This DQ report shall be signed both parts.

该DQ报告应该有双方签署。