Pharma SOPs

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

1.0 OBJECTIVE: To lay down a procedure for the destruction of rubber stereos.2.0 SCOPE: This procedure is applicable to the destruction of rubber stereos in the Production department.3.0 RESPONSIBILITY:Officer, Executive – Production Department, Quality assurance DepartmentManager – Production Department 4.0 PROCEDURE :4.1 Collect the used stereos after completion of packing. Verify that the quantity is … Read more

1.0 OBJECTIVE: To lay down a procedure for indent and approval of rubber stereo for overprinting of batch details on printed packaging material.2.0 SCOPE: This procedure is applicable to indenting and approval of stereo for overprinting of packing material in the production department.3.0 RESPONSIBILITY: Officer, Executive – Production DepartmentManager – Production Department 4.0 PROCEDURE:4.1 Stereo … Read more

1.0 Objective: To lay down a procedure for cleaning of coating solution preparation tank. 2.0 Scope: This SOP is applicable to the cleaning of the coating solution preparation tank in the production department. 3.0 Responsibility:Operator responsible for cleaning Officer, and Executive – Production Department to ensure activity as per given procedureManager – Production Department for … Read more

1.0 OBJECTIVE:   To lay down a procedure for the transfer of finished products to finished goods stores. 2.0 SCOPE:   This procedure is applicable for the transfer of finished products to finished goods stores in the production department. 3.0 RESPONSIBILITY:   Officer, Executive – Production Department Manager – Production Department In charge – Stores … Read more

1.0 Objective: To lay down a procedure for indent, inspection, and maintenance of punches and dies.2.0 Scope: This procedure is applicable to indent, inspection, and maintenance of punches and dies used in the production department.3.0 Responsibility:Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure:4.1 Indent of dies and punches:4.1.1 For ordering a new … Read more

1.0 Objective: To lay down a procedure for cleaning, Operation, and Calibration of Disintegration test apparatus.2.0 Scope: This procedure is applicable to the cleaning, operating, and calibration of the Disintegration test apparatus used in the production department. 3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department, QA Officer – In the process 4.0 Procedure:4.1 Cleaning4.1.1 … Read more

1.0 OBJECTIVE: To lay down the procedure for Cleaning and Operation of the automatic dosing cap pressing machine.2.0 SCOPE: This procedure is applicable for the Cleaning and Operation of the automatic dosing cap pressing machine in the liquid department. 3.0 RESPONSIBILITYOperator, Officer, Executive – Production DepartmentManager – Production Department 4.0 PROCEDURE4.1 Cleaning4.1.1 Batch-to-Batch change over … Read more