厂房设施确认 Qualification Facilities

建筑与设施是指生产所需的厂房/仓库以及工艺配套的公用工程包括：

Building and facility refer to the manufacturing workshops/warehouses and the process utilities, including

- 洁净车间 Clean Areas

- 环境控制仓库 Environmental Control Warehouses

- 空调净化系统HVAC system

- 纯化水系统；Purified Water System

- 工艺气体 Process Gases

计算机化系统验证 Computerized System Validation (CSV)

GMP运行相关的计算机系统应当进行验证，以证明计算机硬件和软件适合所指定的任务。计算机系统应进行很好地控制，以防止未经授权的进入系统，接触或改动数据，此外，建立备份体系以防止电子原始数据的丢失。

Computer system related with GMP operations should be validated to verify that the hardware and software to implement the task.Computer systems should have sufficient controls to prevent unauthorized access or changes to data. Back-up system should be available to prevent loss of electronic raw data in computer system. 

设备确认Equipment Qualification

对产品质量具有潜在影响的关键设备及其辅助设施，如反应釜及其辅助设施、离心机、烘箱，灭菌柜，生物安全柜，罐装机等的确认。

Critical manufacturing equipment and the ancillary systems which have potential impact on the product quality such as reactors and their ancillary systems, centrifuges, driers, sterilization cabinet, biological safety cabinet, canning machine etc.

验证生命周期文件Valication Lifecycle Document

1.Project URS 项目用户需求

2.Project validation plan项目验证计划

3.Impact assessment影响评估

4.DQ设计确认

5.IQ安装确认

6.OQ运行确认

7.PQ性能确认

8.Validation summary report验证总结报告