《斯蒂莫斯纯化水oq_pt_001》由会员分享，可在线阅读，更多相关《斯蒂莫斯纯化水oq_pt_001（49页珍藏版）》请在金锄头文库上搜索。
1、 DOC: OQ-10-012 Rev. 1 Page 1 of 49 Copyright by STILMAS shanghai - All rights reserved - Copy forbidden without authorization. KANGHONG SAGENT PHARMACEUTICAL CHENGDU PEOPLES REPUBLIC OF CHINA OPERATIONAL QUALIFICATION PROTOCOL Water Pre-treatment Plant Type Automatic Softener STS-A-300 Duplex S.N.
2、7008,7009,7010 supplied bySTILMAS shanghai OPERATIONAL QUALIFICATION PROTOCOL DOC: OQ-10-012 Rev. 1 Page 2 of 49 SYSTEM: Water Pre-treatment Plant S.N.:7008-7009-7010 Copyright by STILMAS shanghai - All rights reserved - Copy forbidden without authorization. REVIEW AND APPROVAL PAGE VALIDATION PROTO
3、COL APPROVAL VALIDATION REPORT FINAL APPROVAL The Operational Qualification protocol has been approved for format/content and is acceptable for execution. The Operational Qualification protocol has been completed, the results reviewed and found to be acceptable. PREPARED BY: STILMAS Shanghai EXECUTE
4、D BY: BAOJU SHANGHAI NAME: Jane Jin NAME: JOB TITLE: Validation Engineer JOB TITLE: SIGNATURE: DATE: SIGNATURE: DATE: REVIEWED BY: STILMAS Shanghai REVIEWED BY: BAOJU SHANGHAI NAME: Lucy Zuo NAME: JOB TITLE: Validation Manager JOB TITLE: SIGNATURE: DATE: SIGNATURE: DATE: APPROVED BY: KANGHONG SAGENT
5、 PHARMACEUTICAL APPROVED BY: KANGHONG SAGENT PHARMACEUTICAL ENGINEERING/SYSYSTEM OWNER ENGINEERING/SYSYSTEM OWNER NAME: David Sun NAME: David Sun JOB TITLE: Plant Director of KSP JOB TITLE: Plant Director of KSP SIGNATURE: DATE: SIGNATURE: DATE: VALIDATION DEPARTMENT VALIDATION DEPARTMENT NAME: John
6、 Zazueta NAME: John Zazueta JOB TITLE: Senior Validation Manager of KSP JOB TITLE: Senior Validation Manager of KSP SIGNATURE: DATE: SIGNATURE: DATE: QUALITY ASSURANCE QUALITY ASSURANCE NAME: Lu Benle NAME: Lu Benle JOB TITLE: Associate QA Director of KSP JOB TITLE: Associate QA Director of KSP SIGN
7、ATURE: DATE: SIGNATURE: DATE: OPERATIONAL QUALIFICATION PROTOCOL DOC: OQ-10-012 Rev. 1 Page 3 of 49 SYSTEM: Water Pre-treatment Plant S.N.:7008-7009-7010 Copyright by STILMAS shanghai - All rights reserved - Copy forbidden without authorization. TABLE OF CONTENTS -Cover page -Review and approval pag
8、e -Table of contents 1. DOCUMENT HISTORY. 4 2. SCOPE & PURPOSE. 4 3. RESPONSIBILITIES . 5 3.1 STILMAS shanghai.5 3.2 KANGHONG SAGENT PHARMACEUTICAL .5 3.3 Validation execution contractor.5 4. SYSTEM DESCRIPTION . 6 5. REFERENCE DOCUMENTATION . 6 5.1 Validation documentation.6 5.2 Regulatory Referenc
9、es .6 6. SAFETY ASPECTS. 7 7. VALIDATION PROCEDURE. 8 7.1 General Description .8 7.2 Change Control and Re-Validation .9 7.3 Identification of the Validation Execution Personnel .9 7.4 Amendment(s) and Exceptional Condition(s).10 7.5 Installation Qualification Summary Report.10 7.6 Attachments.11 8. OPERATIONAL QUALIFICATION TESTS. 12 8.1 Prerequisites verification.
