Procedure for Line clearance

  • Line Clearance Procedure varies from area to area and section to section but it is important to ensure that no left-over residues of previous product/unwanted material have been remained otherwise it shall be carried forward to the next product and leads to contamination.
  • It ensures that at all stages of manufacturing/granulation/dispensing/coating etc.. operations carried out before the start of operation / stage during the manufacturing/packing to avoid any contamination or mix ups of the previous product to the next product.
  • Visually check and ensure all the materials (utensil, tools, container, documents etc.) are removed from area, which were used in previous product.
  • Ensure the area for cleanliness & same should be cross verified with usage of cleaning logbook/records.
  • Ensure the temperature and relative humidity is within the specified limit as per mentioned in BMR.
  • Ensure that, the wall, panels, light, fixtures are cleaned in the respective area.
  • Ensure and check that the balances have calibration and status label.
  • Check the wash water analysis report.
  • Ensure that, previous stage of current batch has completed and reviewed by QA.
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