Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco …
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1.0 Objective: To provide a procedure for carrying out Risk assessment, evaluation, mitigation and review of risk by employing appropriate tool of Quality Risk Management Process. 2.0 Scope: Applicable to different aspects of pharmaceutical quality like development, manufacturing, testing, distribution, inspection and submission/review processes throughout the life cycle of drug …
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Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco …
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Factory Acceptance Test for Automatic Strip Packing Machine machine name : AUTOMATIC STRIP PACKING MACHINE Client Name & address : M/S. document name : factory acceptance test PROTOCAL no. : SCT/FAT/000 Revision no. : 00 MACHINE SR. NO. : …
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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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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 Bed 6.2 RPM of Peristaltic pump and Spray Rate 6.3 …
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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 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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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 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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