Production SOPs

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

1.0 Objective: To lay down a Procedure for the Usage, Control, and Storage of Change Parts for liquid orals.2.0 Scope: This procedure is applicable for the proper usage and control of change parts of the Bottle washing machine and Monoblock bottle filling & sealing machine in the liquid department. 3.0 Responsibility:Operator, Officer, Executive – Production … Read more

1.0 Objective: The purpose of this SOP is to lay down the procedure for the operation of the Pharmacode Reader. 2.0 Scope: This SOP is applicable for the operation of a pharmacode reader in the production area. 3.0 Responsibility: 3.1 The production officer/ sr.officer is responsible for the implementation of this sop. 3.2 The Head … Read more

1.0 Objective: To lay down a procedure for Cleaning and Operating of ZEBRA Printer.2.0 Scope: This sop is applicable to the formulation plant Make/Model: ZEBRA3.0 Responsibility: 3.1 Trained worker / Operator shall be responsible for cleaning and operating the machine as per this SOP.3.2 Production Supervisor / Officer shall be responsible for the implementation of … Read more

1.0 Objective: To lay down a procedure for the operation of 37 stations double rotary compression machine.2.0 Scope: This procedure is applicable to the operation of 37 station double rotary compression machines in the production department.3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure:4.1 Ensure that the equipment and area are cleaned and … Read more

1.0 Objective: To lay down a Procedure for Issuance, Use, and Retrieval of the Punches and Dies.2.0 Scope: This procedure is applicable to the issuance, use, and retrieval of the punches and dies used in the production department.3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Issuance of dies and punches:4.1.1 Issue … Read more

1.0 OBJECTIVE: To lay down a Procedure for Making Entries in Equipment Usage Log Book. 2.0 SCOPE: This Procedure for Making Entries in Equipment Usage Log Book in the production department. 3.0 RESPONSIBILITY:Officer, Executive – Production DepartmentManager – Production Department 4.0 PROCEDURE:4.1 Record the usage, cleaning, and preventive maintenance activity of idle time in the … Read more

1.0 Objective: To lay down a procedure for the operation of 35- a station double rotary compression machine.2.0 Scope: This procedure is applicable to the operation of 35- a station double rotary compression machine in the production department.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Ensure that the equipment and … Read more

1.0 Objective: To lay down a procedure for operation calibration and cleaning of IR Moisture Balance.2.0 Scope: This procedure is applicable to operation calibration and cleaning of IR Moisture Balance in the production department.3.0 Responsibility:Operator, Officer, and Executive – Production DepartmentManager – Production Department4.0 Definitions:NA 5.0 Procedure for IR Moisture Balance :5.1 Setting:5.1.1 Adjust the … Read more

1.0 Objective: To lay down a procedure for the destruction of rejected dies and punches.2.0 Scope: This procedure is applicable to the destruction of rejected dies and punches used in the production department. 3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure:4.1.1 Assemble all the defective punch sets, defective upper punches, lower punches, … Read more