Production SOPs

1.0 Purpose: To describe the procedure for tub handling of prefilled syringes of filling machine.2.0 Aim: This Standard Operating Procedure is applicable for tub handling of prefilled syringes of filling machine at Production.3.0 Responsibility:3.1 Officer Production3.2 Head Production4.0 Safety considerations:4.1 Handle the tubs with care while transferring them from one place to another place.4.2 Ensure … Read more

1.0 Purpose: To lay down a procedure for the preparation of rubber bungs.2.0 Aim: This Standard Operating Procedure is applicable for the preparation of rubber bungs. 3.0 Responsibility:3.1 Operator/ Sr. Operator is responsible for carrying out the operation process.3.2 Officers/Executives shall be responsible to supervise the process.3.3 Production-Head/Manager shall be responsible for the implementation of … Read more

1.0 Objective: To lay down a procedure for the Cleaning and Operation of conveyor belt and turn table. 2.0 Scope: This procedure is applicable to the Cleaning and Operation of conveyor belt and turn table in Liquid department. 3.0 ResponsibilityOperator, officer – Production Department 4.0 Procedure4.1 Cleaning4.1.1 Cleaning of conveyer belt4.1.1.1 Start the conveyor belt … Read more

1.0 Objective: To lay down the procedure for the cleaning, Operation of Labeling machine.2.0 Scope: This procedure is applicable to the cleaning, operation of Labeling machine in liquid packing section.3.0 Responsibility: Production Officer, Production Incharge to follow this SOPHead of Department for overall compliance to this SOP. 4.0 Cleaning4.1 General Points:4.1.1 Stop the machine by … Read more

1.0 Objective: To lay down the procedure for Bottle Inspection.2.0 Scope: This procedure is applicable to Bottle Inspection in the liquid department.3.0 Responsibility: Production Executive, Production Manager. 4.0 Procedure:4.1 Before Filling:4.1.1 Receive the washed bottles in the pre-filling inspection box.4.1.2 Inspect the bottles on an optical inspection box consisting of a 60-watt bulb mounted on … Read more

1.0 Objective: To lay down the procedure for Calibration of Dipstick.2.0 Scope: This procedure is applicable for the Calibration of Dipstick in the Liquid Oral department.3.0 Responsibility: Production Officer, Production Executive. 4.0 Procedure:4.1 Take a Plastic bin having about 70 liters capacity and tare it on a suitable calibrated balance.4.2 Fill purified water at 25°C … Read more

1.0 Objective: To lay down a procedure for the sanitization of drain points in pharmaceuticals.2.0 Scope: The procedure is applicable to drain point sanitization in the production area at pharmaceutical companies. 3.0 Responsibility: Housekeeping personnel is to follow this procedure.officers, Executives are responsible to implement this SOP.Manager – Production Department responsible for Overall compliance with … Read more

1.0 Purpose: To lay down the procedure for Washing, sterilization of clean room Garments2.0 Aim: This Standard Operating Procedure is applicable to the Washing, sterilization of clean room Garments in pharmaceuticals.3.0 Responsibility: 3.1 The line operator in operation processes shall carry out the operation process of Washing, and sterilization of clean room Garments.3.2 officers/seniors/executives shall … Read more

1.0 Purpose: To lay down the procedure for cleaning and preparation of filling machine accessories for sterilization.2.0 Applicable: This Standard Operating Procedure is applicable for the cleaning and preparation of filling machine accessories for sterilization on the Production Floor.3.0 Responsibility:3.1 The operator shall carry out the cleaning and preparation process.3.2 officers/Executives shall supervise the process.3.3 … Read more

1.0 Purpose: To lay down the procedure for cleaning and preparation and packing of material for sterilization.2.0 Applicable: This Standard Operating Procedure is applicable to the cleaning, preparation, and of packing of material for sterilization on the production floor.3.0 Responsibility: 3.1 The operators who are trained in cleaning processes shall carry out the cleaning process … Read more

1.0 Purpose: The standard procedure; Aseptic Handling, Operation and Aseptic Connection apply to the aseptic technique which refers to the system of working while performing procedures that are to be carried out under sterile conditions. The aim is to prevent microbial contamination while media simulation, manufacturing products, blending procedures, and aseptic connection. 2.0 Applicable: This … Read more

1.0 Objective: To lay down a procedure for the Operation and cleaning of Fluidized Bed Drier.2.0 Scope: This SOP is applicable to the Operation and cleaning of a Fluidized Bed Drier in the production area.3.0 Responsibility: Operator, Officer, Executive- Production DepartmentManager- Production Department 4.0 Procedure for Operation and Cleaning of Fluidized Bed Drier:4.1 Machine setting: … Read more

1.0 Objective: To lay down a procedure for status labeling in the production department.2.0 Scope: This procedure is applicable to the Status Labeling of equipment, cleaning and disinfectant aids, lubricating aids, in-process materials, and excess packing materials in the production areas.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production DepartmentQA Officer – In the process … Read more

1.0 Objective: To lay down a procedure for the operation of the Blister Pack Machine.2.0 Scope: This procedure is applicable to the operation of the Blister Pack Machine in the production area.3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure for Blister Pack Machine: 4.1 Ensure the area and equipment are … Read more