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Vendor Qualification. Quality Assurance

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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Sani + 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 puriffied 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.

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 Procedure …

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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 : …

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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 : Water for Injection IPA : …

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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 : …

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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 accountable for the compliance of …

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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 be accountable for the compliance …

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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 per SOP. Accountability: …

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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. Procedure: Pre-startup: Check the status of the machine for its operation. Visually check the …

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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 machine is …

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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. Cleaning Procedure At the end of the shift /batch change over …

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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 the compliance of SOP. Abbreviations SOP …

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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 be accountable for the compliance of SOP. …

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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 powder Injectable facility. Responsibility Officers or above (Production) shall be responsible …

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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 Air Flow. Production officer / …

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Operational Qualification of Vertical Laminar Reverse flow Containment Station

PURPOSE: To describe the Operational Qualification of Vertical Laminar Reverse flow Containment Station, its accessories and to define the specification of the system in order to: Ensure that the equipment meets the Operational/Design limits as per user requirements. Ensure that the equipment will be operationally qualified in accordance with current …

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Installation Qualification of Vertical Laminar Reverse Flow Containment Station

PURPOSE To describe the Installation Qualification of Vertical Laminar Reverse Flow Containment Station 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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Operational Qualification of Medicament Preparation Vessel

PURPOSE: To describe the Operational Qualification of Medicament Preparation Vessel, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment shall be operationally qualified in accordance with current Good Manufacturing Practices. …

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