Example-Partial-Cleanroom-OQ.docVIP

Operational Qualification of the Suite D Manufacturing Cleanroom Facility OQ 认作 Document No.: TO-61-2001M Revision: 0 Date: 12-11-09 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) ____________________________________ Manufacturing-Suite D User Function (UF) ____________________________________ Maintenance User Function (UF) System Owner (SO) ____________________________________ Process Control Engineering Control System Owner (CSO) ____________________________________ 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 12/11/09 New document  TABLE OF CONTENTS 1. Protocol Approvals 1 2. Revision History 2 3. Purpose 4 4. Scope 4 5. References 4 6. Responsibilities 5 7. System Description 5 8. Validation Approach 6 9. Executors Instructions 7 10. General Protocol Requirements 7 LIST OF ATTACHMENTS Attachment 1. Signature Log签名 9 Attachment 2. Test Instrument Calibration测试仪器认证 10 Attachment 3. System Calibration系统标定校准 11 Attachment 4. Standard Operating Procedures (SOP) Review标准操作规程(SOP)审核 12 Attachment 5. AHU’s Setpoint VerificationAHU定位点设定的验证 13 Attachment 6. Room Temperature Control Test室内温度控制检测 31 Attachment 7. Room Differential Pressure Test房间压差测试 32 Attachment 8. Tests According to SOP TO-20-EL700 Verification根据标准操作规程(SOP)TO-20-EL700测试 35 Attachment 9. Airflow Visualization (Smoke Pattern) Testing Verification形象化气流(烟气流图案)的测试验 37 Attachment 10. Door Interlock Verification门锁验证