Example- Partial Cleanroom-PQ.docVIP

Performance Qualification of the Suite D Manufacturing Cleanroom Facility SUITE D 公司生产的洁净设备的PQ认证 Document No.: TO-61-2001N Revision: 0 Date: 10/22/09 Document Written by / Date: _____________________________________________ Protocol Approvals Approval of this document indicates agreement with the described validation approach and the defined system challenges. Print Name Signature/Date ____________________________________ Engineering System Builder (SB) ____________________________________ Maintenance User Function (UF) ____________________________________ Manufacturing User Function (UF) System Owner (SO) ____________________________________ Validation Quality Systems Representative (QSR) Post Routing Corrections and E-copy Verification Were all approved hand changes and corrections incorporated into the e-copy? (Yes/NA) Does the e-copy submitted to QAD accurately reflect the approved copy? (Yes) Signature/Date Revision History Revision Date Description Revised By 0 10/22//07 New document TABLE OF CONTENTS 1. Protocol Approvals 1 2. Revision History 2 3. Purpose 4 4. Scope 4 5. References 4 6. Responsibilities 4 7. System Description 5 8. Validation Approach 5 9. Executors Instructions 7 10. General Protocol Requirements 7 目录 1，协议批准一 2，版本修订情况 3，目的 4，范围 5，文献 6，责任 7，系统描述 8，验证方法 9，执行人员操作说明 10，一般协议要求 LIST OF ATTACHMENTS Attachment 1. Signature Log 8 Attachment 2. Test Instrument Calibration 9 Attachment 3. System Commissioning 10 Attachment 4. System Calibration 11 Attachment 5. Standard Operating Procedures (SOP) Review 12 Attachment 6. Personnel Qualification Verification 13 Attachment 8. Day 1 to Day 7 Activities Verification 17 Attachment 7. Airflow Visualization Testing 14 附件列表 附件1，签字日志 附件2，测试仪器校准 附件3，系统调试 附件4，系统标准 附件5，标准操作规程(SOP)复习 附件6，人员之资格检定 附件7，气流可视化检测 附件8，以上7点的审核 Purpose目的 The purpose of this Performance Qualification (PQ) is to demonstrate that the Suite D manufacturing cleanroom facility provides an environment t