Tag Archives: Western Isles

SOP on Transfer of Technology for Manufacturing process

SOP on Transfer of Technology for Manufacturing process Objective: To lay down the procedure for the Transfer of Technology for the Manufacturing Process. Scope: This procedure is applicable for the Transfer of technology (i.e. for the Manufacturing process) from sending unit ( R&D) to receiving site (Manufacturing facility ) Responsibility: …

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SOP on Execution of Exhibit Batches

SOP on Execution of Exhibit Batches  Objective To lay down a procedure for the execution of exhibit batches. Scope This SOP is applicable for the execution of exhibit batches to the formulation plant of a Pharma Company. Responsibility Officer/above of the production and quality assurance department shall be responsible. Accountability …

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Operational Qualification of Ointment Manufacturing Vessel

Operational Qualification of Ointment Manufacturing Vessel PURPOSE: To describe the Operational Qualification of Ointment Manufacturing Vessel, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment shall be operationally qualified in …

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Installation Qualification of Ointment Manufacturing Vessel

  Installation Qualification of Ointment Manufacturing VesselPURPOSE To describe the Installation Qualification procedure to be used during qualification of Ointment Manufacturing Vessel, its accessories and to define the Specification of the system in order to Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the …

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Design Qualification of Ointment Manufacturing Vessel

  Design Qualification of Ointment Manufacturing VesselOBJECTIVE To design, engineer, and supply the Ointment Manufacturing Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in …

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Design Qualification of Blister Packing Machine (Model – BQS)

DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS) TABLE OF CONTENT Objective Scope Responsibility Machine description Technical specification Technical specifications and make of sub-components/ bought out items. Details of Utilities Identification of components for calibration Material of construction of all components Safety features and alarms FAT procedure Change control procedure …

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SOP on Procedure for storage of sterilized rubber stoppers in aseptic area .

Objective To lay down the procedure for storage of sterilized rubber stoppers in aseptic area. Scope This SOP is applicable for storage procedure of sterilized rubber stoppers in aseptic area Production dry powder Injectable facility. Responsibility Production officer / Executive. Accountability Production Head shall be accountable for the compliance of …

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Purified Water -Design qualification pretreatment, generation system

Purified Water -Design qualification pretreatment, generation system To design the equipment / instrument in conjunction with the design data in order to provide basis for vendor, manufacturer & / or the design engineer for designing the system when the project begins. To prepare detailed specification for all major components of …

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Operational qualification for WFI generation plant

Operational qualification for WFI generation plant OBJECTIVE To establish documentary evidence to demonstrate the WS system is qualified for correct operation as per guidelines outlined in this protocol & operational manual SCOPE OF THIS DOCUMENT This protocol is applicable to multi column water. RESPONSIBILITES Inspection Customer or their authorized representatives …

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Design Qualification of Vertical Laminar Reverse Flow Powder Containment Station

OBJECTIVE To design, engineer and supply the Vertical Laminar Reverse Flow Powder Containment Station to provide assurance that the machine is manufactured as per the URS and it complies with the Scope of Supply. To prove that each operation proceeds as per the design specification and the tolerances prescribed there …

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Installation Qualification of Medicament Preparation Vessel

PURPOSE: To describe the Installation Qualification of Medicament Preparation Vessel its accessories and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the installation as per equipment general arrangement Drawing. Ensure that the system installation …

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Design Qualification of Medicament Preparation Vessel

Design Qualification of Medicament Preparation Vessel OBJECTIVE: To design, engineer and supply the Medicament Preparation Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in …

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Operational Qualification of Aluminium Strip Defoiler

PURPOSE To describe the Operational Qualification of Aluminium Strip Defoiler and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices. SCOPE The …

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Dust control during AHU design in Pharma Company

Dust control during AHU design in Pharma Company Dust control in Pharma Company in measure challenge Wherever possible, dust or vapour contamination should be removed at source. Point-of-use extraction, i.e. as close as possible to the point where the dust is generated, should be employed. Spot ventilation or capture hoods may …

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SOP For QUALITY BY DESIGN (QBD) IN PHAARMACEUTICAL PRODUCT

SOP For QUALITY BY DESIGN (QBD) IN PHAARMACEUTICAL PRODUCT INTRODUCTION: The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design (QbD) is emerging …

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Preparation, hahdling, storage and discard of mobile phases

Preparation, hahdling, storage and discard of mobile phases OBJECTIVE To lay down a procedure for the  preparation , handling , storage and discard of mobile phases. SCOPE This SOP shall be applicable for preparation , handling , storage and discard of mobile phases. RESPONSIBILITY Executive/Officer – Quality control ACCOUNTABILITY Head …

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FACILITY VALIDATION PROTOCOL

FACILITY VALIDATION PROTOCOL To ensure that the Facility installed, for the Production Granulation area conforms with the predetermined acceptance criteria. SCOPE OF FACILITY VALIDATION PROTOCOL: – To perform the Facility validation for Production Granulation  area. RESPONSIBILITY: – Validation Executive Engineering Executive Production Executive PROCEDURE: – Check the facility as per …

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SOP Operational Qualification of Raw Gelatin Storage Vessel

SOP Operational Qualification of Raw Gelatin Storage Vessel PURPOSE: To describe the Operational Qualification of Raw Gelatin Storage Vessel, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment shall be …

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SOP For Design Qualification of Raw Gelatin Storage Vessel

SOP For Design Qualification of Raw Gelatin Storage Vessel OBJECTIVE: To design, engineer and supply the Raw Gelatin Storage Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the …

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SOP For Installation Qualification of Encapsulation Machine

SOP For Installation Qualification of Encapsulation Machine PURPOSE To describe the Installation Qualification of Encapsulation Machine along with Tumble Dryer and Gravity Feed Pipes, its accessories and to define the Specification of the system in order to: ensure that the equipment meets the specification as Design Qualification aid verification of …

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