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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 Name Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

INSPECTION [Released / Not Released / Hold / Rejected / Not Applicable]
Inspection Area Room 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 Machine Equipment 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 Inspection Room 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 Balances Instrument 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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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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