Validation & Qualification

SOP for Performance Qualification for Automatic Strip Packing Machine

Performance Qualification for Automatic Strip Packing 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 Sealing Temperature 6.2 Effect …

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SOP for Performance Qualification for Auto Coater 48’’ GMP Model

SOP for Performance Qualification for Auto Coater 48’’ GMP Model 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 Gun Distance from …

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SOP FOR COMPUTER SYSTEM VALIDATION MASTER PLAN

SOP FOR COMPUTER SYSTEM VALIDATION MASTER PLAN Content Approval sheet Introduction Objective Computerized Systems Validation Policy Scope Definitions Role and responsibilities Identification And Categorization of Computerized Systems Validation Strategy and Deliverables Supplier Assessment Quality Risk Management Validation Requirements Documentation Change Control Training Maintenance and Support Document Completion Procedure System Retirement …

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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

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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 Abbreviations …

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DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM

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    …

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Performance Qualification Report for steam steriliser

Performance Qualification Report for steam sterilizer 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 …

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Load Pattern & Justification for steam sterilizer

Load Pattern & Justification for steam sterilizer 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 …

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