Sunday , July 5 2020

Qualification

Performace Qualification Protocol of Dispensing Booth

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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QUALITY RISK MANAGEMENT (RISK ASSESSMENT)

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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Risk Assessment Sample Format on Tablets Manufacturing Process

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

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

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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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 Bed 6.2 RPM of Peristaltic pump and Spray Rate 6.3 …

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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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