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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 the document, are the same at …

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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 Drawing. Ensure that the system …

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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

OBJECTIVE :             To provide procedure for identification, selection, evaluation and qualification of Raw Material (Active and Inactive) and Primary / Printed  Packaging material vendors. RESPONSIBILITY :     Head-SCM  for identification and selection of Vendor. Head – Quality Control for testing of samples. Head – R&D for taking trial of product batches. …

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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

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 specifications and manufacturer’s recommendations The system meets …

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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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SOP for cleaning of cartridge filter

SOP for cleaning of cartridge filter Objective: To lay down a procedure for cleaning of cartridge filter. Scope This SOP is applicable for cleaning of cartridge filter. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. WFI …

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SOP for delabelling and repacking of vials

SOP for delabelling and repacking of vialsObjective: 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 …

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