Production SOPs

1.0 Purpose: To lay down a procedure for the preparation and approval of Bill of material (BOM).2.0 Applicable: This SOP is applicable for the preparation and approval of Bill of Material of different products manufactured at Pharmaceuticals.3.0 Responsibility:3.1 Designated person of Production shall be responsible for the preparation of bill of material for different products … Read more

1.0 Objective: To lay down a procedure for cleaning of shipper sealing machine.2.0 Scope: This procedure is applicable to the cleaning of the shipper sealing machine in the production area.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 TYPE A:Change over from one batch to the next batch of the same … Read more

1.0 OBJECTIVE: To lay down a procedure for shift handover between the Shifts.2.0 SCOPE: This standard operating procedure is applicable for shift handover between the Shifts in the production department.3.0 RESPONSIBILITY: Officer, Executive Production for implementation of this Procedure.Manager Production for Overall compliance with this SOP. 4.0 PROCEDURE:4.1 The following are the instructions to be … Read more

1.0 Objective: To lay down a procedure for the operation of Bin Blender.2.0 Scope: This standard operating procedure Operation of Bin Blender is applicable to the Bin Blender located in the manufacturing area.3.0 Responsibility: Officer, Executive – Production Department follow procedure while executing the operationManager – Production Department for overall compliance 4.0 Procedure for Operation … Read more

1.0 OBJECTIVE: To lay down a procedure for cleaning of Strip Pack Machine.2.0 SCOPE: This procedure is applicable to the cleaning of strip pack machine in the3.0 RESPONSIBILITY: Operator, Officer, and Executive – Production DepartmentManager – Production Department 4.0 PROCEDURE :4.1 TYPE A Cleaning of Strip Pack MachineChange over from one batch to the next … Read more

1.0 OBJECTIVE: To lay down the procedure for cleaning of Liquid tanks, Pipelines, and Filling machine.2.0 SCOPE: This procedure is applicable for cleaning of Liquid tanks, Pipelines, and Filling machine in the liquid Oral department.3.0 RESPONSIBILITY:Production Officer, Production Executive. 4.1 PROCEDURE:4.1.1 Before starting the cleaning, check that the tank is empty and affix the “UNDER … Read more

1.0 Purpose: To describe the procedure for auto-mode Sterilization of Piping System of blending Tanks.2.0 Aim: This Standard Operating Procedure is applicable to auto-mode Sterilization of Piping System of blending Tanks in solution preparation and formulation blending tanks. 3.0 Responsibility: 3.1 Officer/Executive line coordinator shall execute this SOP.3.2 Production Head/designee shall be responsible for implementation … Read more

1.0 Purpose: To lay down the procedure for the operation of the particle counter2.0 Aim: This Standard Operating Procedure is applicable to the operation on the Production floor. 3.0 Responsibility:3.1 Line coordinators shall execute the process.3.2 Officer / Sr. Officer shall check & control the activity.3.3 Production Head shall be responsible for the execution of … Read more

1.0 Objective: To lay down the procedure for Cleaning and Operation of the basket filter assembly.2.0 Scope: This procedure is applicable for the Cleaning and Operation of the basket filter assembly in Liquid orals. 3.0 ResponsibilityOperator, – Production DepartmentOfficer, Executive- Production and QA DepartmentManager – Production and QA Department 4.0 Procedure4.1 Cleaning4.1.1 Remove the “ … Read more

1.0 Purpose: To define the SOP for the Operation of a Stainless Steel Reactor.2.0 Scope: This procedure is applicable to the Operation of all stainless steel Reactor in the Production Department.3.0 Responsibility:Officer/Executive – Production.4.0 Accountability:Head – Production 5.0 Procedure:5.1 Check the “CLEANED” label is affixed to Reactor.5.2 Before starting the operation Check the calibration tags … Read more

1.0 Purpose: To lay down the procedure for cleaning and operating the Automatic strapping (banding) machine.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of the automatic strapping (banding) machine Production floor. 3.0 Responsibility:3.1 The Line coordinators will carry out the cleaning and operation of the banding machine.3.2 Officer of the … Read more

1.0 Purpose: To describe the procedure for operation and cleaning of mobile SIP unit2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of mobile SIP unit.3.0 Responsibility: 3.1 The operator is responsible for operation and cleaning as per SOP.3.2 Officer/Executive shall supervise the process.3.3 Production manager for implementation of SOP.3.4 Head … Read more

1.0 Purpose: To lay down the procedure for the operation and cleaning of tray loading machine.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of tray loading machine, located on the production floor.3.0 Responsibility:3.1 The line coordinators shall carry out the process.3.2 Officers/Executives shall be responsible to supervise the process.3.3 Production … Read more

1.0 Purpose: To lay down a procedure for the operation of Box Cutting and Vial loading.2.0 Aim: This Standard Operating Procedure is applicable to the operation of Box Cutting and Vial loading.3.0 Responsibility: 3.1 Trained operators shall be responsible for Box cutting and vials 3.2 Officers/Sr. Officer for working operation of Box Cutting and Vial … Read more

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