02- IN-PROCESS CHECKS OF GRANULATION/MIXING (PHARMACEUTICALS)

 

                              02- IN-PROCESS CHECKS OF GRANULATION/MIXING    

                                                             (PHARMACEUTICAL)



  PROCEDURE:

  • Check that Manufacturing Order is signed.
  • Check that all the dispensed raw materials (Active & Inactive) have proper identification and their quantities are correct. 
  • Check that the materials, containers, and identification slips of previous batches have been removed.
  • Check that the process identification slip/label has been pasted.
  • Check the cleaning of walls, windows, lights, doors, ceiling, floor, etc.
  • Check that the mixer (Ribbon/spiral), granulator, fluidized bed dryer, cone mixer, and other utensils are properly cleaned.
  • Check that the HVAC system is working properly and note Temp/Humidity.
  • Check that all personnel is wearing protective garments properly.
  • Check that the physical characteristics of raw materials like odor, color, consistency, etc. are as per the required specification.
  • Check that the machine operators are following the SOP while operating.
  • Check that the process is carried on according to SOP.
  • Check that the HVAC system is working properly.
  • Check that all personnel is wearing protective garments properly.
  • Check that the cleaning is maintained throughout the process.
  • Check that the grains are properly stored in Stain Less Steel drums lined with polythene bags.
  • Check that stored material is properly placed on a pallet and in controlled environmental conditions.
  • Check that the material has proper identification slips and is tightly closed.
  •  Check that the physical description of grains is as per the required specification.
  • Check that the material remains in quarantine till Q.C. is Released.
  • Check that the cleaning of the granulation section is started as early as possible.

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