Yearly Archives: 2017

SOP on Execution of Exhibit Batches

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

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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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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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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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