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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PACKING LINE

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PACKING LINE

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

 

 

Stage areas / Equipment Name Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

PACKING [Released / Not Released / Hold / Rejected / Not Applicable]
Packing Line Line 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
Packing Line CLEANLINESS OF
  • Floor
  • Walls
  • Ceiling
  • Container
  • Carets
  • Tools
  • Waste Bins
  • Supply air Grills
  • Return air Grills
  • Light Fixtures
Conveyer Belt Equipment ID No.: _____________

  • Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.
  • Area surrounding the Equipment
Cartooning Machine Equipment ID No.: ______________

  • Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.
  • Area surrounding the Equipment
Online check weigher Equipment ID No.: _____________

  • Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.
  • Area surrounding the Equipment
Shipper sealing machine Equipment ID No.: ______________

  • Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.
  • Area surrounding the Equipment
Shipper weighing balance Equipment ID No.: _____________

  • Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.
  • Area surrounding the Equipment
Shipper strapping machine Equipment ID No.: _____________

  • Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.
  • Area surrounding the Equipment
Manual Coding Room Room ID No.: ________________

  • Ensure the absence of batch documents, labels, materials, or remnants of previous product or batch.
  • Ensure ‘CLEANED’ label is affixed.
CLEANLINESS OF

  • Floor
  • Walls
  • Ceiling
  • Container
 

 

  • Light Fixtures
  • Tools
  • Waste Bins
  • Supply air Grills
  • Return air Grills

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

 

Image result for Packing Line

 

Stage areas / Equipment Name Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Packing Equipment ID No.: ________________

  • Approval of Intermediate product of current batch.
  • BMR of current batch completed up to previous stage.
  • Machine operation 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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