LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING

Pharmaceutical Guidanace November 21, 2018 Audit and Guideline, Production Comments Off on LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING 2,244 Views

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING

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

 

Image result for Primary Packing Area

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 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
  • Light Fixtures
  • Tools
  • Waste Bins
  • Supply air Grills
  • Return air Grills
  • Area under packing Machine
Blister Packing Machine / Strip packing machine / Defoiling Machine Equipment ID No.: ________________

  • Ensure the absence of materials / Powder / tablets / Aluminum foil / PVC foil / PVDC foil / Printed foil / Strips / Blisters or remnants of previous product or batch & traces of water.
  • Pass box cleanliness.
  • Overprinting Stereos of previous batch or product are  destroyed.
  • Area surrounding the Equipment

 

 

 

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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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