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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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 Good Manufacturing Practices SCOPE: The…
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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 installation meets acceptance criteria. Ensure…
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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. SCOPE: The scope of this…
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PURPOSE: To describe the Installation Qualification of Raw 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 installation meets acceptance criteria. Ensure…
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PURPOSE To describe the Installation Qualification procedure to be used during qualification of Aluminium Strip Defoiler to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Ensure that the system installation meets acceptance criteria Ensure that the equipments will be installed in accordance with…
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Deviation Handling and Quality Risk Management This guidance Based on WHO recommended requirements, these documents provide further explanations with examples in order to facilitate implementation. Deviation handling Quality Risk Management was mainly designed to be used prospectively when manufacturing operations are defined and validated. The potential deviations are identified and avoided by implementing risk control…
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