Production

Production

SOP on operation of laminar air flow unit

Objective: To lay down a procedure for operation of laminar air flow unit. Scope This SOP is applicable for operation of laminar air flow unit of Dry Powder Injectable facility. Responsibility Officers or above  Production shall be responsible for follow the procedure mentined in this SOP. Accountability Production Head shall …

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Vial inspection machine

Objective: To lay down a procedure for operation of vial inspection machine. Scope: This SOP is applicable for inspection of filled & sealed vials. Responsibility: Production Officer/ Executive shall be responsible for follow the procedure mentioned in this SOP.. Accountability: Production Head and Head QA shall be accountable for the …

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SOP on assembling of vial filling & bunging machine

Objective: To lay down a procedure for assembling of vial filling & bunging machine. Scope: This SOP describes the procedure for assembling of vial filling & bunging machine. Responsibility: Production operator / technician – responsible for assembling of vial filling & bunging machine. Production officer / Executive – to ensure …

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SOP for operation of strapping machine

Objective: To lay down a procedure for Operation of strapping machine. Scope This SOP is applicable for Operation of Strapping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP: Standard Operating Procedure. No.:Number Procedure Operation of Strapping Machine. Obtain the carry strap roll from production officer.    …

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SOP on Filtration of disinfectant solution and water for injection through cartridge filter.

Objective: To lay down a procedure on filtration of disinfectant solution and water for injection through cartridge filter. Scope This SOP is applicable for filtration of disinfectant solution and water for injection through cartridge filter. Responsibility Officers or above – Production shall be responsible for follow the procedure mentined in …

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SOP on Decartoning of Vials.

Objective: To lay down a procedure for Decartoning of Vials. Scope This SOP is applicable for Decartoning of vials. Responsibility Production officer / Executive. Accountability Production Head and Head QA shall be accountable for the compliance of SOP. Abbreviations Not Applicable Procedure Get the vials issued as per the batch …

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Operation on Bung processor cum steam sterilizer.

Objective: To lay down a procedure for operation of Bung processor cum steam sterilizer. Scope: This SOP is applicable for operation of Bung processor cum steam sterilizer. Responsibility: Production operator / technician – responsible for Operation on Bung processor cum steam sterilizer. Production officer / Executive – to ensure that …

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SOP for washing and inspection of surgical hand gloves.

Objective: To lay down a procedure for washing and inspection of surgical hand gloves. Scope This SOP is applicable for washing and inspection of the surgical gloves used in production area in formulation plant of pharmaceutical company. Responsibility Production Officer / Executive. Accountability Production Head and QA head shall be …

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SOP for cleaning of Pass Box

 Objective To lay down a procedure for cleaning of Pass Box. Scope This SOP is applicable for the procedure of cleaning of Pass Box in the formulation plant of pharmaceutical company. Responsibility Production Operator/ Technician – For the cleaning of the equipment. Production Officer/ Executive– To ensure the cleanliness of …

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SOP for washing and inspection of garments.

SOP for washing and inspection of garments. Objective: To lay down a procedure for washing and inspection of garments. Scope: This SOP is applicable for washing and inspection of garments for dry powder Injection facility in formulation. Responsibility: Production operator / technician – responsible for washing and inspection of garments …

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ASEPTIC PROCESS SIMULATION (MEDIA FILL)

ASEPTIC PROCESS SIMULATION (MEDIA FILL) Aseptic Process Simulation: Process simulation test, which is also synonymously known as media fill, is the aseptic process, where a microbiological growth medium is substituted to the product, which is manipulated and exposed in a similar way to that of the product. PURPOSE Of ASEPTIC PROCESS …

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SOP on usage of Dynamic pass box

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 in formulation plant of pharmaceutical company. Responsibility: Production Officer / Executive shall be responsible for follow the procedure mentioned in this …

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SOP on Control of Sieves and Screens of Different Equipments

Objective:To lay down a procedure for Control of Sieves and Screens of different Equipments. Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company. Responsibility Production Supervisor / Officer shall be responsible for implementation of the procedure as per this SOP. Head-Production / designee shall be responsible for …

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SOP on Control of Change Parts of Machines/Equipments

Objective:To lay down a procedure for the control of change parts. Scope:The standard operating procedure is applicable for formulation plant of Pharmaceutical company for controlling the various change parts of the machines/equipments. Responsibility Trained Worker / Operator shall be responsible for control of change parts. Production Supervisor / Officer shall …

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SOP on Precautions during on line maintenance of machine and re-start operation.

SOP on Precautions during on line maintenance of machine and re-start operation. Objective:To lay down a procedure for precautions during on line maintenance of machine and checks to start its operation. Scope:The standard operating procedure is applicable for formulation plant of Pharmaceutical company. Responsibility Production Supervisor / Officer / Executive …

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SOP on Procedure for Checking of Strips / Blister and Overprinted Packing Materials.

Objective:To lay down a procedure for Checking of Strips / Blister and Overprinted Packing Materials. Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company. Responsibility Production Supervisor / Officer shall be responsible for implementation of this SOP. Head-Production / designee shall be responsible for compliance of this …

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SOP on Precautions during power failure in production area

Objective:To lay down a procedure for precautions during power failure and checks to start the operation. Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company. Responsibility Production Operator / Production Supervisor / Officer shall be responsible for implementation of this SOP. Head-Production / designee shall be responsible …

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SOP on Cleaning and Operating Procedure of Carton Sealing Machine

 Objective:To lay down a procedure for cleaning and operating of Carton Sealing machine. Scope: This standard operating procedure is applicable for formulation plant of pharmaceuticcal company, Make and Model: Tapping System, Identification Number. Responsibility Production Operator shall be responsible for operating the machine as per the procedure mentioned in this SOP. …

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Transfer of Finished Products from Production to Finished Goods Store

Objective:To lay down a procedure for Transfer of Finished Products from Production to Finished Goods Store. Scope:This standard operating procedure is applicable for formulation plant. Responsibility Production Supervisor / Officer shall be responsible for checking the COA from QC, product name, batch number, date of manufacturing, date of expiry, quantity …

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SOP on Filtration of disinfectant solution and water for injection through cartridge filter.

Objective:To lay down a procedure on filtration of disinfectant solution and water for injection through cartridge filter. Scope:This SOP is applicable for filtration of disinfectant solution and water for injection through cartridge filter. Responsibility:Officers or above – Production. Accountability Production Head and QA Head. Procedure Pre Start up Check that …

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