Line clearance in pharmaceutical industry is an important stage for maintaining GMP. It’s a process of providing high degree of assurance that the process line or area is clean, free from previous products and/or any unwanted substances.


A list of common checklist for line clearance in pharmaceutical industry

Line Clearance Checklist for Dispensing:

  • Incoming drums/ containers/ boxes/ bags are cleaned
  • All materials according to Process Order (PO) are available
  • No breakage/ leakage in the container
  • No materials except relevant to this batch are present
  • Correct materials of sufficient amount with approved label
  • All materials &equipment’s/accessories except relevant to this batch are removed
  • All the equipment inside the dispensing room including SS table, utensils and scoops are cleaned.
  • Waste bin is cleaned
  • Exhaust system is working properly
  • Dust collector is properly cleaned
  • All protective clothing of dispensing personnel i.e. dress, shoes, caps, masks, hand gloves are properly cleaned
  • Temperature, Relative Humidity and Pressure Difference should be checked at initial and 01 hour interval and record
  • All the balances and machine/ equipment used are calibrated
  • Check the Mercury bubble of balance is in middle position
  • All materials/ equipments are labeled properly

Line Clearance Checklist for Granulation:

  • All extraneous materials & equipments/accessories except relevant to this batch are removed
  • Waste Bin is cleaned
  • All the equipment inside the room including SS table utensils and scoops arecleaned
  • All materials/ equipments are labeled properly
  • All protective clothing of processing personnel i.e. dress, shoes, caps, masks, hand gloves are properly cleaned
  • Temperature, Relative Humidity and Pressure Difference are within the specified limit
  • All the balances and machine/ equipment used are calibrated
  • Exhaust System working properly
  • Properly Labeled and correct materials are in accordance with BMR.
  • Check that the room and equipment logbook have been completed

Line Clearance Checklist for Compression:
  • All extraneous materials & equipments/accessories except relevant to this batch are removed
  • Correct tooling is set in machine
  • Check and ensure that right IBC has been set up to right compression machine
  • Waste Bin is cleaned
  • All the equipment inside the room including SS table utensils and scoops are cleaned
  • All materials/ equipments are labeled properly
  • All protective clothing of processing personnel i.e. dress, shoes, caps, masks, hand gloves are properly cleaned
  • Temperature, Relative Humidity and Pressure Difference are within the speechified limit
  • All the balances and machine/ equipment are calibrated
  • Exhaust System working properly
  • Properly Labeled and correct materials are in accordance with BMR
  • Check that the room and equipment logbook have been completed

Line Clearance Checklist for Coating:
  • All extraneous materials & equipments/accessories except relevant to this batch are removed
  • Waste Bin is cleaned
  • All the equipment inside the room including SS table utensils and scoops are cleaned
All materials/ equipments are labeled properly
  • All protective clothing of processing personnel i.e. dress, shoes, caps, masks, hand gloves are properly cleaned
  • Temperature, Relative Humidity and Pressure Difference are within the speechified limit
  • All the balances and machine/ equipment are calibrated
  • Exhaust System working properly
  • Properly Labeled and correct materials are in accordance with BMR
  • Check that the room and equipment logbook have been completed


Line Clearance Checklist for Packing area (Primary):
  • Quantity of inner carton for over printing to be determined on the basis of actual number of coated tablets received for blistering after coating
  • All protective clothing of printing personnel i.e. dress, shoes and caps are properly cleaned
  • All extraneous materials & equipment’s/accessories are removed
  • All the balances and machine/ equipment are calibrated
  • Waste Bin is cleaned
  • Plastic drums/containers are cleaned properly
  • Availability of material as per Packaging Order Sheet (POS) and check the correctness
  • Check Forming & Sealing Tool, Guide Rail and Cutting Station are clean
  • Temperature, Relative Humidity and Pressure Difference are checked and found within specified limit

Line clearance activity usually performed by production and quality assurance personnel. This is the initial check point before any process start.