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Validation & Qualification

COMPUTER SYSTEM VALIDATION MASTER PLAN

COMPUTER SYSTEM VALIDATION MASTER PLAN Document No.   Version No. 00 Effective Date   Review Date   Total No. of Pages   INDEX  S. No. Content Page No. 1.0 Approval sheet 2.0 Introduction 3.0 Objective 4.0 Computerized Systems Validation Policy 5.0 Scope 6.0 Definitions 7.0 Role and responsibilities 8.0 Identification And …

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Site Acceptance Test Protocol for Tablet Compression Machine

Site Acceptance Test Protocol for Tablet Compression Machine machine name :  35 STN “B” TOOLING TAB COMPRESSION  MACHINE     Client Name & address :     document name : SITE ACCEPTANCE TEST PROTOCOL     PROTOCAL no. :     Revision no. : 00     MACHINE SR. NO. …

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Factory Acceptance Test for Tablet Compression Machine

machine name : 35 STN “B” TOOLING TAB, COMPRESSION MACHINE     Client Name & address :     document name : factory acceptance test     PROTOCAL no. :     Revision no. : 00     MACHINE SR. NO. :   Table of Contents 1.SYSTEM DESCRIPTION 2.SYSTEM CHECKES …

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Performance Qualification for Tablet Compression Machine

Performance Qualification for Tablet Compression Machine TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 4.1 Equipment Identification 4.2 Description of Operation 4.3 Standard Operating Procedure Established During Operation Qualification 5.0 Validation Plan and Methodology 6.0 Performance Qualification Procedure 6.1 Effect of Machine Speed 6.2 Effect of …

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OPERATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT

OPERATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM TABLE OF CONTENTS Pre-Approval Overview Purpose Requalification System Distribution System Description Operational Qualification Procedure Pre Requisite for OQ Test Test Equipments Qualification of Execution Team Inspection Checklist Operational Qualification Instrument Calibration Key Functionality Operational Checks SOP verification Deficiency, if any …

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INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT

INSTALLATION   QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM TABLE OF CONTENTS   Sr. No Description Page No. 1 Objective 2 System / Equipment Description 3 Responsibility 4 Execution Team 5 Installation Verification 6 Installation Check 7 Documentation Requirement 8 Deviation Report 9 Installation Qualification Summary & Conclusion 10 …

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DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM

TABLE OF CONTENTS 1.0       DESIGN QUALIFICATION PROTOCOL APPROVAL 2.0       INTRODUCTION 3.0       OBJECTIVE: 4.0       SCOPE 5.0       RESPONSIBILITY 6.0       BASIS OF DESIGN 7.0       SYSTEM DESCRIPTION 8.0     SCOPE OF SUPPLY AND TECHNICAL SPECIFICATIONS 9.0       PANEL INTERLOCKS AND OPERATIONAL LOGICS 10.0    CRITICAL SAFETY REQUIREMENTS 11.0    SAMPLING PLAN 12.0    SANITISATION CYCLE 14.0    LIST OF APPROVED …

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Validation Observations Recording Format -I for steam steriliser and load Pattern

Recording Of Observations For Revalidation Identification Of The Executors   S. No. Name Designation & Department Sign & Date Training Details         Steam Quality Tests Steam Non-Condensable Gas Test When the temperature of the water in the container reaches 70-75°C close the needle valve. Note the volume …

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Performance Qualification Report for steam steriliser

REPORT APPROVAL Performance Qualification is verified that all test cases required by the protocol are completed, reconciled and included in the qualification summary report. Signatures in the block below indicate that all items in this Qualification Report have been reviewed and found to be acceptable. SUMMARY REPORT Data generated during …

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Load Pattern & Justification for steam steriliser

APPROVAL SIGNATURES Signing of this approval page of load pattern indicates agreement with the qualification approach described in PQ protocol. If any modification in the load pattern becomes necessary, a revision through change control shall be prepared, checked and approved. Wherever applicable revalidation of the modified load pattern shall be …

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