Line Clearance , Purpose:
Line Clearance , To lay down the Procedure for Line Clearance at the Packaging Area.
Line Clearance , Scope:
This SOP is applicable for the Packaging Area of XX Pharmaceuticals Limited.
Definition / Abbreviation:
Line Clearance : Line Clearance is a method of assuring components, labels, and documents have been removed and accounted from the previous work order for before starting a new work order and to make certain the line is properly prepared for the next work order.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]To follow the laid down procedure
Executive, Packaging
[][]To monitor and check the laid down procedure
Manager, Production
[][]To implement this correctly
Manager, Quality Assurance
[][]To approve the Document
Procedure:
Precautions:
[][]Ensure the proper safety instructions are followed.
[][]Ensure that no previous product is available in the area.
[][]Line Clearance during Product to Product Changeover
[][]Clean all utility lines like compressed air line, air inlet ducts and return air risers with dry mop to remove loose dust from the floor.
[][]Clean the door, floor, walls and ceiling with dry cloth & finally wet mop.
[][]Area cleaning activity is recorded in ‘Room Cleaning Log book’
[][]Clean all equipment in the area according to their respective SOPs and no traces of previous product are visible within the equipment.
[][]Check and ensure that equipment cleaning activity is recorded in respective ‘Equipment Log Book’
[][]Ensure that Span between equipment usage and cleaning is not more than seventy two hours.
[][]Balances, if available in the packaging area, are cleaned and accuracy check is done before use.
[][]Fresh set of gowns are issued to concerned operators.
[][]Proper environmental condition is maintained in the area and the records of the same are maintained in the specified formats.
[][]Ensure the correctness of Batch Packaging Record.
Line Clearance during Batch to Batch Changeover
[][]Ensure that previous batch material is removed from the packaging area.
[][]Ensure that all equipment and their spares are cleaned according to their respective SOPs.
[][]Ensure that equipment cleaning activity is recorded in respective ‘Equipment Log Book’.
[][]Ensure that floor is cleaned using vacuum cleaner and no visible traces of the previous batch materials on the floor.
[][]Proper environmental condition is maintained in the area and the records of the same are maintained in the specified formats.
[][]Ensure the correctness of Batch Packaging Record.
Annexure:
Annexure I Equipment Use Log Book