SOPs
STANDARD OPERATING PROCEDURE Title: Procedure For Quality Risk Management Department: Quality Assurance OBJECTIVE This SOP defines the approach to Quality Risk Management (QRM) of a GMP site which may be used to facilitate the process and to aid personnel performing the assessment. SCOPE Applicable to any process at a GMP site that requires a Risk…
SOP for Operating Procedure for Gelatin Storage Vessel Check the ‘CLEANED’ status label duly filled and signed on the Gelatin Storage Vessel, then unwrap the cling film. Ensure the cleanliness of the Gelatin Storage Vessel. Affix ‘BATCH IN-PROCESS’ status label on Gelatin Storage Vessel duly filled and signed. Record all observations in line clearance record….
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OPERATION OF REVERSE OSMOSIS SYSTEM To provide the operating procedure for the Reverse Osmosis system. This procedure covers the operating procedure for the Reverse Osmosis system. PROCEDURE The Reverse Osmosis system is fed with softened water stored in a tank with a capacity of 5000 Liter. The feed pump pumps water from the tank to…
Cleaning procedure for Softened Water Storage Tanks To implement the cleaning procedure for Softened Water Storage Tanks. This SOP covers the cleaning procedure for Softened Water Storage Tanks. Procedure: Ensure that there is no production activity in the concerned area. Turn off the tank which should be cleaned and put a sign “UNDER PREVENTIVE MAINTENANCE”…
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To implement and procedure of the replacement procedure for the Purified Water Pump. This SOP covers the replacement procedure for the Purified Water Pump. PROCEDURE Ensure that there is no production activity in the concerned area. Turn on the Reverse Osmosis system and put a sign “UNDER PREVENTIVE MAINTENANCE”. Drain water from the purified water…
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The procedure of storing uniforms for microbiological analysis To lay down the Procedure of storing uniforms for microbiological analysis This SOP is applicable to provide the long and qualitative operation of UV -cabinets,s and the sterility of used materials. PROCEDURE: General cleaning After another replacement germicidal lamp: Power off the UV cabinet. Thoroughly clean the…
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Operation and calibration procedures of viscometer Operation and calibration procedures of viscometer. PROCEDURE Plugin the instrument Start the instrument by pressing the ON/OFF button on the back panel The following is displayed: REMOVE SPINDLE PRESS ANY KEY REMOVE SPINDLE PRESS ANY KEY Remove the spindle and press any key. The following is displayed: REPLACE SPINDLE…
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Waste treatment procedure for medicinal products which must be utilized/destructed OBJECTIVE To provide waste treatment procedure for medicines which must be utilized/destructed. SCOPE This SOP is applicable to waste treatment compliance of medicines which must be utilized/ destructed. RESPONSIBILITY Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY QC…
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Physical and chemical quality control test of purified water OBJECTIVE To provide the procedure of purified water quality control. SCOPE This procedure is applicable to the quality control of purified water in the sampling point. RESPONSIBILITY Quality Control Analyst shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY Quality Control and Head…
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Refresher training of QC physical-and-chemical laboratory staff OBJECTIVE To provide QC physical-and-chemical laboratory staff with the information about the necessity of refresher training for more effective work. SCOPE This SOP is applicable to QC physical-and-chemical laboratory staff. RESPONSIBILITY Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY QC Head…
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