SOP

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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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SOP for operation of rapid mixer granulator (RMG) with cone mill

SOP for operation of rapid mixer granulator (RMG) with cone mill Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of rapid mixer granulator with cone mill. Scope  This SOP is applicable for operation of rapid mixer granulator with cone mill to the formulation plant. Responsibility Production …

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Cleaning of Rapid Mixer Granulator with Cone Mill

Cleaning of Rapid Mixer Granulator with Cone Mill Standard Operating Procedure (SOP) Objective: To lay down a procedure for cleaning of Rapid Mixer Granulator with cone mill. Scope: This SOP is applicable for the cleaning of Rapid Mixer Granulator with cone mill located in oral section at formulation plant. Responsibility: …

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SOP on cleaning of Paste Kettle

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

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SOP for operation of Metal Detector

SOP for operation of Metal Detector Standard Operating Procedure (SOP) Objective: To lay down a procedure for operation of metal detector. Scope: This SOP is applicable for the operation of metal detector to the formulation plant. Responsibility: Production Operator/ Technician shall be responsible for operation of the machine. Production Officer/Executive …

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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 – For …

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Contract production, analysis and other activities as per WHO Guideline

Contract production, analysis, and other activities Principle. Contract production, analysis and any other activity covered by GMP must be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a product, or work or analysis, of unsatisfactory quality. All arrangements for contract production and analysis, including …

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Pharmaceutical Manufacturing Premises – Risk classification observations

Pharmaceutical Manufacturing Premises – Risk classification guide for drug good manufacturing practices observations Risk 1 (critical) observations There was no air filtration system to eliminate airborne contaminants likely to be generated during fabrication or packaging. There was generalized malfunctioning of the ventilation system(s), with evidence of widespread cross-contamination. Segregation of …

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Process Validation: General Principles (USFDA)

Process Validation: General Principles (USFDA) This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes. FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle. The lifecycle concept links product and process …

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Management Review

Management Review Objective To have a systematic approach for quality review as per Quality Management System (QMS) with a objective to monitor product quality, validated status of products and related processes, identify improvements required in manufacturing process and systems and take care of quality risks throughout product life-cycle. Scope This …

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SOP on Standard Operating Procedures

SOP on Standard Operating Procedures Objective: To lay down a procedure for preparation, review, approval, distribution, control & revision of Standard Operating Procedure. Scope: This procedure is applicable to all SOP’s of the formulation plant of Pharmaceutical Company. Responsibility: Personnel (originating department) – Preparation of SOPs. Department Head / nominee …

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