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Tag Archives: Dundee

Observation & Risk classification of Equipment during Inspection (Pharmaceutical)

EQUIPMENT Manufacturing equipment should be designed, located and maintained to suit its intended purpose. Repair and maintenance operations should not present any hazard to the quality of the products. Manufacturing equipment should be designed so that it can be easily and thoroughly cleaned. It should be cleaned according to detailed …

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SOP for operation of Strip Packing Machine

SOP for operation of Strip Packing Machine Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of Strip Packing Machine. Scope  This SOP is applicable for the operation of Strip Packing Machine used to pack the Tablets and Capsules into Strips in the formulation plant. Responsibility Production …

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SOP on operation of Paste Kettle

SOP on operation of Paste Kettle Standard Operating Procedure (SOP) Objective To lay down the procedure for operation of Paste Kettle Scope This SOP is applicable for operation of Paste Kettle in the formulation plant. Responsibility Production Operator/ Technician – For operation of the equipment. Production Officer/ Executive – To …

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SOP for cleaning of Fluid Bed Dryer

SOP for cleaning of Fluid Bed Dryer Standard Operating Procedure (SOP) Objective: To lay down a procedure for cleaning of Fluid Bed Dryer. (Make: Alliance, Model: 250 Kg) Scope: This SOP is applicable for the cleaning of fluid bed dryer Make: Alliance Model: 250 kg. Responsibility: Operator –To perform the …

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SOP for operation of tablet compression machine

SOP for operation of tablet compression machine Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of tablet compression machine. Scope This SOP is applicable for operation of tablet compression machine to the formulation plant. Responsibility Operator/ Technician shall be responsible for operation of the machine Production …

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DESIGN QUALIFICATION OF AHU

DESIGN QUALIFICATION OF AHU  TABLE OF CONTENTS S.No TITLES PAGE No. 1.0 PURPOSE 3 2.0 SCOPE 3 3.0 PROJECT REQUIREMENT 3 3.1 AIR HANDLING UNIT 4   3.1.1 BASIS OF DESIGN 4   3.1.2 BASIS OF DESIGN AND ASSUMPTION 5   3.1.3 CRITICAL VARIABLES TO BE MET 5-10 4.0 COMPONENTS …

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SOP for cleaning of FBD bag

SOP for cleaning of FBD bag Standard Operating Procedure (SOP) Objective To lay down a procedure for cleaning of FBD bags. Scope This SOP is applicable for the cleaning of FBD bags in the formulation plant. Responsibility Production Operator/ Technician – For cleaning of the equipment. Production Officer/ Executive – …

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SOP for operation of Tablet Inspection Machine

SOP for operation of Tablet Inspection Machine Standard Operating Procedure (SOP) Objective To lay down the procedure for operation of Tablet Inspection Machine. Scope This SOP is applicable for the operation of Tablet Inspection Machine in the formulation plant. Responsibility Production Operator/ Technician – For operation of the machine. Production …

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SOP for operation of Auto coater.

SOP for operation of Auto coater Standard Operating Procedure (SOP) Objective 1.1             To lay down a procedure for operation of Auto coater. Scope 2.1             This SOP is applicable for operation of Auto coater in the formulation plant. Responsibility Production Operator/ Technician – For operation of the machine. Production Officer/Executive …

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Document Management System in Quality Assurance Department.

Document Management System in Quality Assurance Department Standard Operating Procedure (SOP) Objective: To lay down a procedure for Management of Documents in Quality Assurance Department. Scope: Applicable for Document Management system in Quality Assurance department. Responsibility: Quality Assurance Department Accountability: Head- QA shall be accountable for compliance of this SOP. …

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