LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR INSPECTION LINE

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR INSPECTION LINE

Dosage Form:Date / Time:
Product:Batch No.  :
Previous product:Batch No.  :

Image result for tablet inspection belt

Stage areas / Equipment NameChecksChecked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

INSPECTION [Released / Not Released / Hold / Rejected / Not Applicable]
Inspection AreaRoom ID No.: ________________

  • Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch.
  • Ensure ‘CLEANED’ label is affixed on each equipment.
  • Ensure updation of Status Board
  • Temperature [24 ± 2°c]
  • Relative Humidity [35 – 50 %]
  • Differential Pressure [10 – 26 Pascal]
CLEANLINESS OF

  • Floor
  • Walls
  • Ceiling
  • Drain
  • Container
  • Light Fixtures
  • Tools
  • Waste Bins
  • Supply air Grills
  • Return air Grills
  • Area under Inspection Machine
  • Area under the balance
Inspection MachineEquipment ID No.: __________________

  • Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch and traces of water or colour.
CLEANLINESS OF

  • Base of the belt
  • Illumination of the belt
  • Cleaned label present
  • Reject tray
  • Integrity of rollers
  • Conveyor belt
  • Hopper
  • Tablet modifier
  • Inside the belt
  • Rollers
Manual InspectionRoom ID No.: ____________________

  • Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch.
  • Ensure ‘CLEANED’ label is affixed on each equipment.
  • Ensure updation of Status Board
  • Temperature [24 ± 2°c]
  • Relative Humidity [35 – 50 %]
  • Differential Pressure [10 – 26 Pascal]
  • SS trays
  • Inspection Table
Weighing BalancesInstrument ID No.: ____________________

CLEANLINESS OF

  •  Balance Platform
  • Balance display
  • Balances are Calibrated
  •  Area surrounding the balance

 

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 

 

 

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