Production

Production

SOP on usage of Dynamic pass box

Objective: To lay down a procedure on usage of Dynamic pass box. Scope This SOP is applicable for usage of Dynamic pass box ID.No PIDPB-01, PIDPB-02, PIDPB-03 and PIDPB-04. Responsibility Production Officer / Executive. Accountability Production Head shall be accountable for compliance of SOP. Abbreviations SOP : Standard Operating Procedure. …

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SOP for cleaning of garment washing machine.

Objective: To lay down the procedure for cleaning of garments washing machine. Scope  This SOP is applicable for cleaning of garments washing machine. Responsibility Production operator / technician – responsible for cleaning of garment washing Production officer / Executive – to ensure that cleaning of garment washing machine is carried …

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SOP for operation of Air borne particle counter.

Objective: To lay down a procedure for operation of air borne particle counter. Scope This SOP is applicable for operation of air borne particle counter. Responsibility Officers or above (Production) shall be responsible for the operation of air borne particle counter. Accountability Production-Head shall be accountable for the compliance of …

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SOP for preparation of disinfectant solution

Objective: To lay down a procedure for preparation of disinfectant solution. Scope This SOP is applicable for preparation of disinfectant solution at dry powder Injectable facility. Responsibility Officers /above –(Production Injectable) is responsible for preparation of disinfectant solution. Accountability Production Head shall be responsible for the compliance of the SOP. …

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Production Question and Answer

1.Question: Definition of Good Manufacturing Practices (GMP) as per WHO ? Answer: WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.” GMP covers …

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Sop for operation of BOPP taping machine

Objective: To lay down a procedure for operation of BOPP taping machine. Scope This SOP is applicable for operation of BOPP taping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. BOPP : Biaxial Oriented Polypropylene IPQA : In-process Quality Assurance Procedure Pre-Start …

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SOP on operation of packing conveyer belt

Objective To lay down the procedure for the operation of packing conveyer belt. Scope:  The SOP is applicable for the operation of packing conveyer belt installed in the packing hall of sterile injectables facility.  Responsibility Officers and above-Production Accountability Production Head Abbreviations MCB : Miniature Circuit breaker Procedure Ensure that …

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SOP for operation of inkjet printing machine

Objective: To lay down a procedure for operation of Ink jet printing machine. Scope This SOP is applicable for operation of Ink jet printing machine (make:Image). Responsibility Officers or above – Production.  Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. LCD : Liquid Crystal Display Procedure Start-up Ensure the …

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SOP for operation of carton coding machine

Objective:To lay down a procedure for operation of carton coding machine. Scope: This SOP is applicable for operation of carton coding machine. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. No.: Number Date : Manufacturing Date Date : Expiry Date MRP : Maximum …

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SOP For Decartoning of primary and secondary packing materials.

Transfer the required quantity of seals from warehouse to decartoning room on the receipt of the packing material requisition slip. Decartoning of Seal Decartoning of Rubber Stopper Transfer the required quantity of stopper from warehouse to decartoning room on the receipt of the packing material requisition slip. The production officer …

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SOP for sterilization of media.

SOP for sterilization of media. Objective: To lay down a procedure for sterilization of media. Scope: This SOP is applicable for sterilization of media. Responsibility: Production Officers / Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability: Production Head and QA Head shall be accountable for …

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SOP for Cleaning and Sanitization of Drain Point.

SOP for Cleaning and Sanitization of Drain Point. Objective: To lay down a procedure for cleaning and sanitization of drain point. Scope: This SOP is applicable for cleaning and sanitization of drain point. Responsibility: Production Officers / Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability: …

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SOP on Steps to be taken in case of Environmental Failure

Objective To lay down the steps to be taken in case of environment failure in the aseptic area of Sterile Dry Powder Injectables facility. Scopе This SOP describes the steps to be taken in case of environmental failure. Responsibility Production Officers / Executive shall be responsible for follow the procedure …

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SOP on Destruction And Disposal of Media Filled Vials

SOP on Destruction And Disposal of Media Filled Vials Objective: To lay down a procedure on destruction and disposal of media filled vials. Scope This SOP is applicable for destruction and disposal of media filled vials. Responsibility Production officer / Executive shall be responsible for follow the procedure mentined in …

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SOP on Fumigation in Aseptic Area

Objective To lay down a procedure for fumigation in aseptic area. Scope The SOP describes the procedure for fumigation in aseptic area. Responsibility Production Officer / Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability Production Head and Qa head shall be accountable for compliance of …

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SOP on cleaning of return air riser filters.

Objective: To lay down a procedure for cleaning of return air riser filters. Scope This SOP is applicable for cleaning of return air riser filters. Responsibility Production Officers / Executive shall be responsible for follow the procedure mention in this SOP. Accountability Production Head and QA Head shall be accountable …

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SOP on cleaning of packing conveyor belt.

Objective: To lay down a procedure for cleaning of packing conveyor belt Scope This SOP is applicable for cleaning of packing conveyor belt. Responsibility Officers or above of Production personnel shall be responsible for follow the procedure mentioned in this SOP. Accountability Production Head and QA Head shall be accountable …

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SOP for Bowie dick test

Objective: To lay down a procedure for bowie dick test Scope: This SOP is applicable for Bowie Dick test in pharmaceutical plant. Responsibility: Production Officers /Executive shall be responsible for follow the procedure mentioned in this SOP.. Accountability: Production Head shall be accountable for the compliance of SOP. Abbreviations SOP …

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SOP for washing, siliconization and sterilization of Rubber stopper.

Objective: To lay down a procedure for washing, siliconization, sterilization and drying of Rubber stopper. Scope: This SOP is applicable for washing, siliconization, sterilization and drying of Rubber stopper. Responsibility: Production Officers/ Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability: Production Head shall be accountable …

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SOP on integrity testing of cartridge filter.

Objective To lay down a procedure for integrity testing of cartridge filter. Scope This SOP is applicable for integrity testing of cartridge filter in formulation plant. Responsibility Production officer / Executive shall be responsible for follow the procedure mentined in this SOP. Accountability Production Head and QA Head shall be …

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