Material and Man Flow, Purpose :
Material and Man Flow, To lay down the procedure of Material and Man Flow to the Production and Packaging Area for Dialysis Fluid .
Material and Man Flow, Scope :
This SOP is applicable for the Concern Personnel of Production and Packaging of Dialysis Fluid Unit(DFU) of the XX Pharmaceuticals Limited.
Definition / Abbreviation:
[][]BOM = Bill of Material
[][]QAD = Quality Assurance Department
[][]DFU= Dialysis Fluid Unit
Responsibilities:
[][]The roles and responsibilities are as follows:
Operator
[][]To follow the laid down procedure.
Laundry Man
[][]To provide cleaned garments.
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly.
Head of Quality Assurance
[][]To approve the SOP.
Annexure:
N/A
Precautions :
[][]Do not step on the floor with bare foot.
[][]Rub hands with Disinfectant Solution before entering into the Production Area.
[][]Jewelry, Wrist Watch, Finger Ring & Ear Ring is not allowed to Production Area.
[][]No food is allowed to Production Area.
[][]Shoe>Cover >Cap >Apron >Mask.
[][]After wearing company provided dress, stand in front of the mirror and confirm that, clothing is covering full arms and cap is covering all hairs according to the sample photos displayed.
[][]Proceed towards the DFU Unit.
MAN FLOW ( Starting from D Change ) :
[][]Before entering into the primary change room, Personnel should complete secondary change as per procedure.
[][]Enter into the Primary Change Room.
[][]Rub hands with Disinfectant Solution (70% Iso-Propyl Alcohol).
[][]Open the door of Corridor, turn left side and proceed to the Production as well as Container Washing Area of DFU.
MATERIALS FLOW ( Starting from Ware-House, Solid Block ) :
[][]Collect Materials from Cargo Lobby (less than 25 Kg) for dispensing at the Dispensing Booth (GPR009) of General Block.
[][]Ensure that, around 25 Kgs. in a single Bag / Pack transfers directly to the DF Unit Air-Lock.
[][]Ensure that, all the materials dispensed as per BOM are to be needed to transfer to the Manufacturing Area of the DFU.
[][]Liquid Material (Glacial Acidic Acid) is to be collected from the Flammable Storage Area.
[][]Filled Containers (10L) are to be transferred to the Secondary Packaging Area of General Block by using transfer trolley.
[][]The received Filled Containers (10L) are taken to the Packaging Conveyor for proper Wiping, Labeling and Packaging.
[][]Packed Products as a whole batch are to be taken to the Quarantine Area on Pallets for QA Release.
[][]After getting QA Release Slip, the Finished Goods (as a whole batch) are to be transferred to the Central Ware-House through the Warehouse of Solid Block.