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SOP

Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules

OBJECTIVE : To provide procedure for representative sampling of  In-process blends, uncoated tablets, coated tablets and filled capsules. RESPONSIBILITY : Officer – Quality Assurance. Head – Quality Assurance to ensure compliance. PROCEDURE : After receiving the “Inprocess Analysis Request and report / Inprocess analysis request for commercial batches/Analysis Request “(Annexure …

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Procedure for line clearances. Quality assurance.

OBJECTIVE To ensure that the area, equipment and activities required for the manufacturing and packing of pharmaceutical products are free from any potential sources of cross contamination / mix-ups (Line clearance). SCOPE The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities. Responsibility …

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MAINTENANCE OF VENTILATION SYSTEMS (EXHAUST)

OBJECTIVE            To lay down a procedure for Maintenance of Ventilation System SCOPE This SOP is applicable to Ventilation System (Exhaust).  RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Weekly Maintenance Check condition of the belt for wear, tear and damage and replace if damaged and  clean the area with …

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MAINTENANCE OF VENTILATION SYSTEMS (SUPPLY)

OBJECTIVE            To lay down a procedure for Maintenance of Ventilation System SCOPE  This SOP is applicable to Ventilation System (Supply). block. RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Weekly Maintenance Check condition of the belt for wear, tear and damage and replace if  damaged and  clean the area …

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CLEANING OF WATER OVER HEAD TANKS & SUMPS

OBJECTIVE                                               To lay down a procedure for Cleaning of Water Over Head Tanks and Sumps SCOPE  This SOP is applicable to Water Over Head Tanks and Sumps. RESPONSIBILITY             Technical Supervisor / Engineer ACCOUNTABILITY                     Sr.Executive / Manager PROCEDURE Obtain work permit for carrying out cleaning. Ensure that all safety precautions are …

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MAINTENANCE OF DEHUMIDIFIERS, BRY-AIR MAKE, MVB MODEL

OBJECTIVE                                               To lay down a procedure for Maintenance of Dehumidifier SCOPE This SOP is applicable to all Dehumidifiers. RESPONSIBILITY             Technical Supervisor / Engineer ACCOUNTABILITY                     Sr.Executive / Manager PROCEDURE Daily Maintenance Check and ensure no unusual noise form the Actuator motor, Process air & Reactivation motor. Ensure the motor should be …

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MAINTENANCE OF SCREW CHILLER MAKE: YORK

OBJECTIVE                                               To lay down a procedure for Maintenance of Screw Chiller SCOPE This SOP is applicable to Screw Chiller. RESPONSIBILITY             Technical Supervisor / Engineer ACCOUNTABILITY                     Sr.Executive / Manager PROCEDURE Daily Maintenance  Check and ensure oil level as per the mark …

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MAINTENANCE OF DISPENSING BOOTH

OBJECTIVE         To lay down a procedure for Maintenance of Dispensing booth SCOPE This SOP is applicable to Dispensing booth. RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Quarterly Maintenance            Check and ensure the free rotation of the blower motor shaft. Check the full load current in all phases …

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Submission of new SOP and changes to existing SOP

OBJECTIVE :    To provide a system for initiating a new SOP and to update an existing SOP. RESPONSIBILITY : The Department Head/Section In charge shall ensure that all SOPs pertaining to their department are prepared/updated and routed for approval. Procedure :             Submission of new SOP :                 The request for a …

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MAINTENANCE OF FINISHED GOODS STORES AIR CONDITIONING SYSTEM MAKE: BLUE

OBJECTIVE            To lay down a procedure for Maintenance of Finished Goods Stores Air Conditioning system SCOPE This SOP is applicable to Finished Goods Stores Air Conditioning System, Model: ACU20B, Capacity: 18 Ton of Refrigeration. RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Daily Maintenance Check and ensure that …

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