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Line Clearance Checklist point production/packing

Before proceed to pack a product, the Production officer and Q.A. officer shall verify the Area as per the given line clearance checklist point in BMR/BPR records. During Line clearance, all points shall be complied with to ensure product quality and to prevent contamination, Mixup, and cross-contamination.

Line Clearance Checklist point for Primary Area:

  • Are cleaned labels affixed on equipment?
  • Is the statue’s board updated?
  • Is the Area is cleaned as per the frequency and types of cleaning?
  • Are Area temperature and Relative humidity are within limits?
  • Is the Differential pressure of the Area is under control limits?
  • Are the personnel following proper gowning procedures?
  • Is the area waste bin empty out?
  • Check Is Area free from previous product residues?
  • Is the product waste container is cleaned and devoid of previous batch material?
  • Rubber Stereo of the previous batch is removed and destroyed?
  • Metallic stereo of the previous batch is removed and retrieved?
  • Is the Area below the machine is cleaned as per cleaning requirements?
  • Is the Area devoid of the foil of the previous batch?
  • Are Blister/strip Machine parts are cleaned and free from previous products residues?
  • Are the following parts of the Blister/ strips machine cleaned? 1. Hopper and bowl 2. Product collector and vibrator/ Dust collector hood 3. Chute channel 4. Above and below the conveyor belt
  • Check the BPR is completed up to the last stage.
  • Are the Documents pertaining to the previous batch removed from the Area?
  • Open the side panel of the machine and check it is free from the previous batch product?
  • Check Is the toolbox devoid of previous batch products?
  • Is the De-blistering/ de-stripping are cleaned as per relevant SOPs?

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