Tag: Quebec

FACTORY ACCEPTANCE TEST FOR BLISTER PACK MACHINE

Posted on By ABHA

FACTORY ACCEPTANCE TEST FOR BLISTER PACK MACHINE machine name: BLISTER PACK MACHINE. Client Name & Address: M/S BLISCARE MACHINES, MUMBAI. document name: factory  acceptance test Table of Contents SYSTEM DESCRIPTION & SALIENT FEATURES SYSTEM CHECKS : Physical Check : TECHNICAL SPECIFICATIONS TECHNICAL SPECIFICATIONS OF SUBCOMPONENTS/BOUGHTOUTS MATERIAL OF CONSTRUCTION VENDOR & CLIENT REMARK  SYSTEM DESCRIPTION :…

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Qualifications & Validations, Blister Machine

PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION

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PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION 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 Powder Level in Hopper 6.3 Effect…

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Qualifications & Validations, Compression Machine

Factory Acceptance Test for Tablet Compression

Posted on By ABHA

Factory Acceptance Test for Tablet Compression machine name : FALCON B4 TYPE 35 STN “B” TOOLING TAB, MACHINE Client Name & address : FALCON, AHMEDABAD, INDIA document name : factory acceptance test PROTOCOL no. : Revision no. : 00 MACHINE SR. NO. : Table of Contents  1.… SYSTEM DESCRIPTION :………………………………………………………………………………………………….. 2.… SYSTEM CHECKES :…………………………………………………………………………………………………………. 2.1…

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Qualifications & Validations, Compression Machine

Site Acceptance Test Protocol for Tablet Compression

Posted on By ABHA

Site Acceptance Test Protocol for Tablet Compression machine name : FALCON B4 TYPE 35 STN “B” TOOLING TAB, MACHINE Client Name & address : FALCON, AHMEDABAD, INDIA document name : SITE acceptance test PROTOCOL PROTOCOL no. : Revision no. : 00 MACHINE SR. NO. : Table of contents Sr. No. Title Page No. 1.0         Approval…

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Qualifications & Validations, Compression Machine

USER REQUIREMENT SPECIFICATIONS OF COMPRESSION MACHINE

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USER REQUIREMENT SPECIFICATIONS OF COMPRESSION MACHINE Sr. No. Table of Contents 1 General 2 Salient Features 3 Operational Requirements 4 Utilities 5 Maintenance 6 Commissioning and Documentation 7 Training 8 Packaging 9 Deviations 10 Delivery  TECHNICAL SPECIFICATION  S. No. Parameters Required Specifications 1.0 General Equipment No.     Description Use FIeld Identification Sound Reduction: The…

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Compression Machine, Qualifications & Validations

INSTALLATION QUALIFICATIONS OF COMPRESSION MACHINE

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INSTALLATION QUALIFICATIONS OF COMPRESSION MACHINE TABLE OF CONTENT Purpose Scope Responsibilities Procedure Installation Qualification tests Documents & Drawings Verification Verification of Technical Specification for In-House & sub-components / Bought out items Utilities Verification Material of Construction Verification Critical Instrument calibration verification Installation Qualification Tests Status Data Analysis, Summary of IQ & Recommendations Amendment Record Conclusion…

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Qualifications & Validations, Compression Machine

OPERATIONAL QUALIFICATIONS OF COMPRESSION MACHINE

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OPERATIONAL QUALIFICATIONS OF COMPRESSION MACHINE TABLE OF CONTENT Purpose Scope Responsibilities Procedure Operational qualification tests Main Panel / Control Panel Testing Power & Communication Failure Recovery Verification Safety Features Verification Variable RPM verification Operational Qualification Tests Status List of Standard Operating Procedures Data Analysis, Summary of OQ & Recommendations Amendment record Conclusion PURPOSE To describe…

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Compression Machine, Qualifications & Validations

Handling of Out of Specification Results

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Handling of Out of Specification Results 1.0 OBJECTIVE: To lay down a procedure for handling of Out-of-Specification (O.O.S.) test results generated during the testing. 2.0 SCOPE : These procedures are applicable to all QC testing of raw materials, finished product, and stability samples. 3.0 RESPONSIBILITY : Analyst/ Quality Assurance Manager 4.0 ACCOUNTABILITY : Quality Assurance Manager 5.0…

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SOPs

PROCEDURE FOR OPERATION OF UNIT DOSAGE SAMPLER

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PROCEDURE FOR OPERATION OF UNIT DOSAGE SAMPLER 1.0  OBJECTIVE :  To lay down the procedure for operation and cleaning of unit dose sampler. 2.0  SCOPE :  This SOP shall be applicable for IPQA area in Quality Assurance. 3.0  RESPONSIBILITY : In process Quality Assurance Executive /Officer 4.0  ACCOUNTABILITY : Head Quality Assurance 5.0  PROCEDURE FOR OPERATING…

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SOPs

SAMPLING OF PACKING MATERIALS

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SAMPLING OF PACKING MATERIALS 1.0  OBJECTIVE : To lay down a procedure for sampling of packaging materials. 2.0  SCOPE : To describe the procedure for sampling of Primary packing materials i.e. Aluminium Foil, Blister Aluminium Foil, PVC Film etc. and secondary packing materials i.e. Cartons, labels, Leaflet shipper etc. 3.0  RESPONSIBILITY :Quality Control Executive/Officer 4.0 ACCOUNTABILITY : Quality…

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SOPs