Home » Production » Line Clearance Checklist point Production/packing

Line Clearance Checklist point Production/packing

Before starting to pack any product, the Production officer and Q.A. officer should check the area based on the line clearance checklist mentioned in the BMR/BPR records. While conducting line clearance, make sure to follow all points to ensure product quality and prevent contamination, mix-up, and cross-contamination.

Line clearance checklist

Line Clearance Checklist point for Primary Area:

  • Are cleaned labels affixed on equipment as per the status labeling procedure?
  • Is the statue’s board updated?
  • Is the Area cleaned as per the frequency and types of cleaning?
  • Area temperature and Relative humidity are within limits?
  • Is the Differential pressure of the Area under control limits?
  • Do the personnel follow proper gowning procedures?
  • Is the area waste bin empty out?
  • Check if the Area is free from previous product residues.
  • Is the product waste container 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 cleaned as per cleaning requirements?
  • Is the Area devoid of the foil of the previous batch?
  • Are Blister/Strip/ BQS Machine parts cleaned and free from previous product 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 BMR/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 cleaned as per relevant SOPs?

Related Post: Checklist for BMR Release

  • Naresh Bhakar

    Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has exprience in Pharma manufactring and worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don't hesitate to reach out via email at [email protected].

Sharing Is Caring:

Leave a Comment