Before proceeding to pack any 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 to ensure product quality and better prevention from product contamination, Mixup, and cross-contamination.
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?
- Are the personnel follows proper gowning procedure?
- Is the area waste bin empty out?
- Check if 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?
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