Gelatin Colour Mixer A Gelatin Colour Mixer is a semi-automatic machine used for mixing color and another additive with melted gelatin mass. The machine is provided with an in-built hydraulic system to lift / down the top lid. The top lid has an I-bolt to fix the jacketed storage vessel with it. The stirrer is…
Installation Qualification of Gelatin Storage Vessel To describe the Installation Qualification of the Gelatin Storage Vessel and its accessories and to define the Specification of the system to: Ensure that the equipment meets the specifications as per Design Qualification. Aid verification of the installation as per equipment general arrangement Drawing. Ensure that the system installation…
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Design Qualification of Gelatin Storage Vessel OBJECTIVE: To design, engineer and supply the Gelatin Storage 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 the document, are the same…
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Vendor Qualification SOP To provide a procedure for identification, selection, evaluation and qualification of Raw Material (Active and Inactive) and Primary / Printed Packaging material vendors. Responsibility of Vendor Qualification SOP : Head-SCM for identification and selection of Vendor. Head – Quality Control for testing of samples. Head –…
Chemical Sanitization Procedure for RO first Pass Objective : To Disinfectant the Bacteria in RO membrane Scope :- Procedure : Prepare (0.1 – 1) % Minncare Solution in any solution preparation tank having the capacity of 300 Ltr { Use 300ml of 100% Minncare in 300 Ltrs of Purified Water at Ambient Temp} Connect…
Installation qualification for purified water generation system This Installation Qualification Protocol shall be performed on the Purified Water Generation System. This protocol defines the methods and documentation that shall be used to evaluate the system for installation by the manufacturer’s specifications and intended use. Successful completion of this protocol shall verify that this system meets…
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SOP for sterilization of Miscellaneous Items Objective: To lay down a procedure for sterilization of miscellaneous Items. Scope: This SOP is applicable for sterilization of Miscellaneous Items. Responsibility: Officers/above (Production-Injectable) is responsible for sterilization of Miscellaneous Items. Accountability: Production Head is accountable for the implementation and compliance of this SOP. Abbreviations SOP : Standard Operating…
SOP for sterilization of cartridge Filter Objective: To lay down a procedure for sterilization of cartridge filter. Scope: This SOP is applicable for sterilization of cartridge filter pre assembled in filter housings. Responsibility: Production Officers / Executive. Accountability: Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure MMI…
What is a Cartridge Filter A cartridge filter is a type of filter that employs a porous cartridge as the medium for trapping impurities from liquids or gases. It is usually made of materials like paper, polyester, or other synthetic fibers, and its design allows for efficient filtration by trapping particles of varying sizes. Cartridge…
SOP for delabelling and repacking of vials Objective: To lay down a procedure for Delabelling and Repacking of vials. Scope This SOP is applicable on procedure for Delabelling and Repacking of vials for Production dry powder Injection facility. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations…
SOP for cleaning of vial filling machine and its parts Objective To lay down a procedure for cleaning of vial filling machine and its parts. Scope This SOP is applicable for cleaning of vial filling machine and its parts for Production dry powder Injection facility. Responsibility Production Officers / Executive. Accountability Production Head shall be…
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SOP on cleaning of Liquid filling machine (Watson Marlon ) Objective: To lay down the procedure for cleaning of liquid filling machine (Watson Marlon). Scope This SOP is applicable for the procedure of cleaning of liquid filling machine shall be accountable for the compliance of SOP. Responsibility Production Officers / Executive. Accountability Production Head shall…
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SOP for operation of sticker labeling machine (Maharshi) Objective: To lay down a procedure for operation of sticker labeling machine. Scope: This SOP is applicable for sticker labeling machine. Responsibility: Production operator/Technician- responsible for operation of sticker labeling machine. Production officer/ Executive – to ensure that operation of sticker labeling machine is carried out as…
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SOP for operation of shrink wrapping machine Objective: To lay down a procedure for operation of shrink wrapping machine. Scope: This SOP is applicable for shrink wrapping machine. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. MASTER FORMULA OF MEBENDAZOLE TABLETS Procedure: Pre-startup: Check the status of the…
SOP on cleaning of shrink wrapping machine Objective: To lay down a procedure for cleaning of shrink wrapping machine. Scope This SOP is applicable for cleaning of shrink wrapping machine in production area. Responsibility Production operator / technician – responsible for cleaning of machine. Production officer / Executive – to ensure that cleaning of the…
SOP for cleaning of sticker labeling machine (Maharshi) Objective: To lay down a procedure for cleaning of sticker labeling machine. Scope This SOP is applicable for the cleaning of sticker labeling machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. MASTER FORMULA OF COLD TABLETS Cleaning Procedure At…
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SOP for operation & cleaning of electronic balance 50Kgs (lakshmi Samson) Objective: To lay down a procedure for operation & cleaning of electronic balance 50kgs (Make Lakshmi Samson) Scope This SOP is applicable for operation & cleaning of electronic balance 50kgs (Make Lakshmi Samson). Responsibility Production officer/ Executive Accountability Production Head shall be accountable for…
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SOP for operation & cleaning of electronic balance 3 Kgs (lakshmi Samson) Objective: To lay down a procedure for operation & cleaning of electronic balance 3 kgs (Make Lakshmi Samson) Scope This SOP is applicable for operation & cleaning of electronic balance 3 kgs (Make Lakshmi Samson). Responsibility Production officer/ Executive Accountability Production Head shall…
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SOP on cleaning of Aspirator assembly and disposal of waste raw material collected during filling operation. Objective To lay down the procedure for cleaning of aspirator assembly and disposal of waste raw material collected during filling operation. Scope This SOP is applicable for cleaning of aspirator assembly and disposal of waste raw material in Dry…
SOP for cleaning of PVC flaps of Laminar Air Flow To lay down a procedure for cleaning of PVC flaps of Laminar Air Flow. Objective: Scope This SOP is applicable for cleaning of PVC flaps of Laminar Air Flow. Responsibility Production operator / Technician – responsible for operation of cleaning of PVC flaps of Laminar…
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