Pharma Editor

Design Qualification of Gelatin Colour Mixer

Design Qualification of Gelatin Colour Mixer OBJECTIVE: To design, engineer and supply the Gelatin Colour Mixer 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 …

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Installation Qualification of Gelatin Storage Vessel

Installation Qualification of Gelatin Storage Vessel PURPOSE: To describe the Installation Qualification of Gelatin Storage Vessel its accessories and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the installation as per equipment general arrangement …

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Design Qualification of Gelatin Storage Vessel

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 …

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Vendor Qualification SOP

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 …

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Sanitization & Cleaning SOP ( RO )

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 …

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Installation qualification for purified water generation system

Installation qualification for purified water generation system Purpose  The purpose of this protocol is to provide an outline for the inspection of the system for static attributes to verify that: Each installed sub-component complies with the engineering design and system data sheets/specifications. The system is installed according to the design …

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SOP for sterilization of Miscellaneous Items

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. …

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SOP for sterilization of cartridge Filter

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 …

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Cartridge Filter

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 …

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SOP for delabelling and repacking of vials

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 …

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SOP for cleaning of vial filling machine and its parts

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. …

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SOP on cleaning of Liquid filling machine (Watson Marlon )

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 / …

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SOP for operation of sticker labeling machine (Maharshi)

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 …

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SOP for operation of shrink wrapping machine

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: …

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SOP on cleaning of shrink wrapping machine

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 …

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SOP for cleaning of sticker labeling machine (Maharshi)

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 …

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SOP for operation & cleaning of electronic balance 50Kgs (lakshmi Samson)

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 …

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SOP for operation & cleaning of electronic balance 3 Kgs (lakshmi Samson)

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/ …

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SOP on cleaning of Aspirator assembly and disposal of waste raw material collected during filling operation.

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 …

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SOP for cleaning of PVC flaps of Laminar Air Flow

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 …

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