称量罩PQ验证方案.docx

Dispensing Booth Performance Qualification Protocol 称量罩性能确认方案 xxxx Pharmaceutical Co., Ltd. xxxx制药有限公司 2013年11月 Protocol Approval/方案批准: ——部门、职务 Department, Title姓名 Name签名 Signature日期 Date编制人 Author验证管理员 Validation Administrator审核人 Reviewed 质量中心副总监（验证） Associate Quality Director （Validation）工程中心负责人 Project Center Director生产中心负责人 Production Center Director质量中心负责人 Quality Center Director质量保证部主管 QA Supervisor批准人 Approved质量保证部经理 QA Manager目录Index  TOC \o 1-3 \h \z \u  HYPERLINK \l _Toc359509530 1. 介绍Introduction  PAGEREF _Toc359509530 \h 4  HYPERLINK \l _Toc359509531 2. 目的Purpose  PAGEREF _Toc359509531 \h 4  HYPERLINK \l _Toc359509532 3. 范围Scope 5  HYPERLINK \l _Toc359509535 4. 职责Responsibilities  PAGEREF _Toc359509535 \h 5  HYPERLINK \l _Toc359509539 5. 缩略语Abbreviations  PAGEREF _Toc359509539 \h 6  HYPERLINK \l _Toc359509540 6. 法规和指南Regulations and Guidelines  PAGEREF _Toc359509540 \h 7  HYPERLINK \l _Toc359509543 7. 参考文件References 8  HYPERLINK \l _Toc359509544 8. 系统/设备描述System/Equipment Description 9  HYPERLINK \l _Toc359509548 9. 文件管理规范Documentation Control Procedure 9  HYPERLINK \l _Toc359509549 10. 测试项目列表Test List 11  HYPERLINK \l _Toc359509550 11.性能确认测试Installation Qualification Test  PAGEREF _Toc359509550 \h 11  HYPERLINK \l _Toc359509557 12.验证事件处理Validation Events Handling 22  HYPERLINK \l _Toc359509567 13. 性能确认报告Installation Qualification Report  PAGEREF _Toc359509567 \h 22  HYPERLINK \l _Toc359509568 14. 附件清单Attachment List  PAGEREF _Toc359509568 \h 24  HYPERLINK \l _Toc359509569 15. 支持性附录清单Support appendix list  PAGEREF _Toc359509569 \h 24  HYPERLINK \l _Toc359509570 16. 附件 Attachment  PAGEREF _Toc359509570 \h 26  介绍Introduction 目的Purpose 本性能确认方案的目的是提供文件证据证明称量罩能基于批准的工艺方法和产品标准，进行有效的重复的运行。 The purpose of this PQ is to provide documented evidence that Dispensing Booth can perform effectively and reproducibly, based on the approved p