Pharma SOPs

1.0 Objective: To lay down a procedure for the return of excess packing material in production department to stores.2.0 Scope: This SOP is applicable for the return of excess packing material in production department to stores.3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department4.0 Definitions:NA 5.0 Procedure:5.1 After completion of the packing activity, Reconcile the … Read more

1.0 Objective: To lay down a procedure for the management of sieves/ screens / FBD bowl mesh.2.0 Scope: The procedure is applicable to check the inventory and integrity of sieves/ screens / FBD bowl mesh in the production department.3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department4.0 Definitions:NA 5.0 Procedure:5.1 For Inventory:5.1.1 On intimation of … Read more

1.0 Objective: To lay down a procedure for the cleaning of SS / HDPE containers, Inprocess containers (IPCs), Blender Bins, pallets, new sieve/screen, and accessories.2.0 Scope: This procedure is applicable for cleaning SS / HDPE containers, Inprocess containers (IPCs), Blender Bins, pallets, SS items, new sieve/screens, and accessories in the production department.3.0 Responsibility:Operator, Officer, Executive … Read more

1.0 OBJECTIVE: To lay down a procedure for coding accessories.2.0 SCOPE: The procedure is applicable to the coding of accessories in the production department.3.0 RESPONSIBILITY:Officer, Executive – Production DepartmentManager – Production Department4.0 DEFINITION(S):Accessories: sieves, screens, FBD finger bag and RMG filter bag, scoops, blender bin, etc. in the production area. 5.0 PROCEDURE:5.1 Procedure to be … Read more

1.0 Objective: To lay down a procedure for the operation of a tablet inspection belt.2.0 Scope: This procedure is applicable to the operation of tablet inspection belt in production area.3.0 Responsibility:Operator, Officer, Executive – Production DepartmentManager – Production Department4.0 Definition:NA 5.0 Procedure:5.1 Operation:5.1.1 Ensure the cleanliness of equipment and area.5.1.2 After line clearance from QA, … Read more

1.0 OBJECTIVE: To lay down the procedure for the Cleaning and Operation of the Monoblock Filling and Sealing Machine. 2.0 SCOPE: This procedure is applicable for the Cleaning and Operation of the Monoblock Filling and Sealing Machine in the liquid department. 3.0 RESPONSIBILITYOperator, Officer, Executive – Production and QA DepartmentManager – Production and QA Department … Read more

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