SOP on Destruction of Rubber Stereos

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

SOP on Indent and Approval of Rubber Stereo for Overprinting

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

SOP on Cleaning of Coating Solution Preparation Tank

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

SOP on Transfer of Finished Products to Finished Goods Stores

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

SOP on Indent, Inspection, and Maintenance of Punches and Dies

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

SOP on Disintegration Test (DT Apparatus ) Cleaning, Operation, and Calibration

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

SOP on Cleaning, Operation of the Automatic Dosing Cap Pressing Machine

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

SOP On Movement of Material from One Stage to Another

1.0 Objective: To lay down a procedure for the movement of material from one stage to another.2.0 Scope: This procedure is applicable for the movement of material from one stage to another stage during various processes in the production department.3.0 Responsibility:Operator, Officer, and Executive – Production DepartmentManager – Production Department4.0 Definitions:NA 5.0 Procedure:5.1 Store to … Read more

SOP on Operation of Filter Press

1.0 Objective: To lay down the procedure for operation of Filter Press.2.0 Scope: This procedure is applicable for the operation of the Filter Press in the liquid oral department.3.0 Responsibility:Production Officer, Production Executive. 4.0 Procedure:4.1 Assembling:4.1.1 The filter press consists of 9 sets of filter plates, mesh, and non-woven filter pads alternating with each other.4.1.2 … Read more

SOP on Monitoring Temperature, Relative Humidity, and Differential Pressure

1.0 Objective: To lay down a procedure for monitoring temperature, relative humidity, and differential pressure in the production area.2.0 Scope: This procedure is applicable to the monitoring of temperature, relative humidity, and differential pressure in the production area.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure:4.1 Recording of Temperature and relative humidity:4.1.1 … Read more

SOP on Inventory and Storage of Sieves, Screens

1.0 Objective: To lay down a procedure for Inventory and storage of sieves, screens. 2.0 Scope: This procedure is applicable to Inventory management and storage of sieves, screens. 3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Inventory4.1.1 On intimation of receipt from stores, collect all the sieves/screens from the … Read more

SOP on cleaning of new equipment/machinery

1.0 OBJECTIVE: To lay down a procedure for cleaning of new equipment/machinery / in-process product containers/accessories received. 2.0 SCOPE: This procedure is applicable to the cleaning of new equipment/machinery / In-process product containers/accessories in the production department. 3.0 RESPONSIBILITY:Officer, Executive – Production DepartmentManager – Production Department 4.0 DEFINITION(S): Accessories: Sieves, screens. Spatulas, scoops SS jugs, … Read more

SOP on Handling Products During a Power Failure

1.0 OBJECTIVE: To lay down a procedure for handling products during a power failure in the production area.2.0 SCOPE: This procedure is applicable to the handling of products during a power failure in the production area.3.0 RESPONSIBILITY:Officer, Executive – Production Department, Quality AssuranceManager – Production Department, Quality Assurance4.0 DEFINITION(S):NA 5.0 PROCEDURE: 5.1 Action to be … Read more

SOP on Cleaning and Operation of Printing and Rewinding Machine for Labels.

1.0 Purpose: To lay down the standard operating procedure for cleaning and operation of printing and rewinding machine for labels.2.0 Aim: This Standard Operating Procedure is applicable for cleaning and operation of printing and rewinding machines for labels.3.0 Responsibility:3.1 Trained line -Coordinators for cleaning and operation of the machine.3.2 Officers/ Sr. officers shall respectively supervise … Read more

SOP on Procedure for Non-Viable Particle Count (Locations, limits, and Frequency)

1.0 Purpose: To lay down a procedure for Locations, limits, and frequency of nonviable particle count.2.0 Aim: This SOP is applicable to nonviable particle count locations, limits, and their frequency in the Production facility.3.0 Responsibility:3.1 Sr. Officer / Officer & line coordinator shall execute this SOP.3.2 In-charge / Head shall supervise that the process is … Read more

SOP on the Procedure for Packing Vials

1.0 Purpose: To lay down the procedure for packing vials.2.0 Aim: This Standard Operating Procedure is applicable for packing vaccine vials in the Packing Section.3.0 Responsibility: 3.1 Trained operators and casual workers shall be responsible for packing activity.3.2 Officer/ Senior officer of Production shall be responsible for checking the activity.3.3 IPQA person shall be responsible … Read more