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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COATING

Pharmaceutical Guidanace November 19, 2018 Audit and Guideline, Audit and Routine Checklist Comments Off on LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COATING 1,448 Views

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COATING

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

Image result for coating machine

Stage areas / Equipment Name Checks Checked by

Production

Date & Time

 Counter checked By Quality Assurance

Date & Time
COATING [Released / Not Released / Hold / Rejected / Not Applicable]
Coating Room 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
  • Tools
  • Waste Bins
  • Light Fixtures
  • Area under coating Machine
  • Area under the Colloidal mill
  • Area under the coating solution
  • preparation tank
  • Area under the coating solution
  • storage tank
  • Area under the balance
  • Supply air Grills
  • Return air Grills
Auto-coater Equipment ID No.: __________________

  • Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water or colour on each dismantle part.
  • Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Exhaust hood
  • Base of the Dosing Pump
  • Cleaned Label Present
  • Connecting Pipes
  • View Glass Integrity (intact)
  • Temperature probe
  • Sampling Probe
  • Light assembly
  • Hot air blower
  • Spray Guns
  • Baffles
  • Cabinet
  • Pan
  • Spray gun Bar
  • PLC assembly
  • Peristaltic Pump
Colloid Mill 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.

 

Colloid Mill CLEANLINESS OF

  • Cleaned Label Present
  • Rotor
  • Hopper
  • Hose pipe
  • Stator
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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