Product Changeover, Purpose :
Product Changeover, To lay down the Procedure of Product Change Over to the Production and Packaging Area during Product to Product changeover and Batch to Batch Changeover for Dialysis Fluid Unit(DFU)
(DFU).
Product Changeover, Scope :
This SOP is applicable for the Concern Personnel of Production and Packaging of DFU Unit at XX Pharmaceuticals Limited.
Definition / Abbreviation :
N/A
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.
Precautions :
[][]Ensure the proper safety instructions are followed.
[][]Ensure that no previous product is available in the area.
Product to Product Changeover :
[][]Ensure that, all utility lines like compressed air line, steam line, electrical fixtures, air inlet ducts, return air risers, potable water and purified water lines are cleaned and no visible traces of product are present.
[][]Ensure that Outer surface of machine, table, door, floor, walls and ceiling are cleaned.
[][]Ensure that Pre-mixing, Mixing, Storage, Filling Vessel to be clean with plenty of water (First time Potable Water Finally Purified water).
[][]Ensure that area cleaning activity is recorded in ‘Room Cleaning Log Book’
[][]Ensure that all equipments in the area are cleaned 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.
[][]Ensure that Balances in the production area are cleaned and accuracy check is done before use.
[][]Ensure that production utensils like scoops, spatula, sieve stand, punch trolley, pallets, BMR table and tool boxes are cleaned as per procedure.
[][]Ensure that all equipments are labeled as ‘CLEANED’.
[][]Ensure that fresh set of gowns are issued to concerned operators.
[][]Ensure that 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 Manufacturing Record / Batch Packaging Record.
Batch to Batch Changeover :
[][]Ensure that previous batch material is removed from the production area.
[][]Ensure that all the equipment and their spares are cleaned according to their respective SOPs.
[][]Ensure that equipment cleaning activity is recorded in respective ‘Equipment Log Book’.
Annexure:
Annexure I Equipment Use Log Book