Checklist for Line Clearance in Manufacturing : Pharmaceutical Guidelines

Checklist for Line Clearance in Manufacturing

Line clearance is useful to ensure the cleanliness of the manufacturing area. It is good manufacturing practices requirement to prevent the mix up and cross contamination in pharmaceutical products. This checklist will help in line clearance.

Line Clearance Checklist for Dispensing

  1. Check and ensure that the area/ equipment are visually clean.
  2. Check the area is free from previous product and unwanted materials
  3. Ensure the temperature and relative humidity is within the specified limit as per mentioned in BMR.
  4. Check the differential pressure of the area is –ve with respect to the adjacent corridor.
  5. Check the proper gowning of personnel.
  6. Check the present status label which shows the detail of Activity.
  7. Ensure the RLAF is working properly.
  8. Ensure that the balance is calibrated.
  9. Check the raw material for the name, material codes, appearance, AR No., expiry/ retest date etc.
  10. Ensure the cleanness of the container in which dispensing is to be done.

Line Clearance Checklist for Granulation

  1. Check and ensure that the area/ equipment are visually clean.
  2. Check the area is free from previous product and unwanted materials
  3. Ensure the temperature and relative humidity is within the specified limit as per mentioned in BMR.
  4. Check the differential pressure of the area is –ve with respect to the adjacent corridor.
  5. Check the proper gowning of personnel.
  6. Check the present status label which shows the detail of the activity.
  7. Ensure that the balance is calibrated and verify the weight of dispensed materials
  8. Check the integrity of sieve and FBD bag.
  9. Ensure the availability of BMR
  10. Check the wash water analysis report.

Line Clearance Checklist for Compression

  1. Check and ensure that the area/ equipment are visually clean.
  2. Check the area is free from previous product and unwanted materials
  3. Ensure the temperature and relative humidity is within the specified limit as per mentioned in BMR.
  4. Check the differential pressure of the area is –ve with respect to the adjacent corridor.
  5. Check the proper gowning of personnel.
  6. Check the present status label which shows the detail of the activity.
  7. Check the wash water/ swab analysis report.
  8. Check the blend analysis report is passing.
  9. Ensure the availability of BMR and filled upto the stage.
  10. Ensure the correct dies and punches.

Line Clearance Checklist for Coating

  1. Check and ensure that the area/ equipment are visually clean.
  2. Check the area is free from previous product and unwanted materials
  3. Ensure the temperature and relative humidity is within the specified limit as per mentioned in BMR.
  4. Check the differential pressure of the area is –ve with respect to the adjacent corridor.
  5. Check the proper gowning of personnel.
  6. Check the present status label which shows the detail.
  7. Check the wash water/ swab analysis report.
  8. Check the core tablet analysis report.
  9. Ensure the availability of BMR and filled upto the stage.

Line Clearance Checklist for Packing Cubicles (Tablet & Capsule)

  1. Check and ensure that the area/ equipment are visually clean.
  2. Check the area is free from previous product and unwanted materials
  3. Ensure the temperature and relative humidity is within the specified limit as per mentioned in BPR.
  4. Check the differential pressure of the area is –ve with respect to the adjacent corridor.
  5. Check the proper gowning of personnel.
  6. Check the present status label which shows the details.
  7. Verify the issued primary packaging material with respect to BPR
  8. Check the previous product stereo are destroyed.
  9. Check the foil specimen for its Batch No., Mfg date, Exp date, price etc.
  10. Ensure the availability of BPR and filled upto the stage.
  11. Check the tablet inspection and release status.

Line Clearance Checklist for Packing Line (Tablet & Capsule)

  1. Check and ensure that the area/ equipment/ belt are visually clean.
  2. Check the area is free from previous product and unwanted materials
  3. Check the proper gowning of personnel.
  4. Check the present status label which shows the details.
  5. Verify the issued secondary packaging material with respect to BPR
  6. Ensure the availability of BPR and filled upto the stage.
  7. Check the carton, show box and shipper specimen for its Batch No., Mfg date, Exp date, price etc.
  8. Ensure the check weigher are functioning properly.
  9. Check the cleaning of cartonator M/C and free from the previous product.
  10. Ensure the REJECTED LABELED container is available for rejected strip/ blister
  11. Ensure the filling quantity of carton/ shipper.

Line Clearance Checklist for Liquid Manufacturing

  1. Check and ensure that the area/ equipment/ tank is visually clean.
  2. Check the area is free from previous product and unwanted materials
  3. Ensure the temperature and relative humidity are within the specified limit as per mentioned in BMR.
  4. Check the present status label which shows the details.
  5. Check the proper gowning of personnel.
  6. Ensure the availability of BMR and filled upto the stage.
  7. Ensure that the balance is calibrated and verify the weight of dispensed materials.
  8. Ensure the filter press is cleaned.
  9. Check the wash water report of the tank.

Line Clearance Checklist for Filling of Liquid

  1. Check and ensure that the area/ equipment/ are visually clean.
  2. Check the area is free from previous product and unwanted materials
  3. Ensure the temperature and relative humidity are within the specified limit as per mentioned in BMR.
  4. Check the present status label which shows the details.
  5. Check the proper gowning of personnel.
  6. Ensure the availability of BPR and filled upto the stage
  7. Check the wash water report of tank/ nozzles.
  8. Check the filled volume of bottles(total no of nozzles)
  9. Ensure the dust bin is clean and wrap with new poly bags.

Line Clearance Checklist for Packing Line (Liquid)

  1. Check and ensure that the area/ equipment/ belt are visually clean.
  2. Check the area is free from previous product and unwanted materials
  3. Check the proper gowning of personnel.
  4. Check the present status label which shows the details.
  5. Verify the issued secondary packaging material with respect to BPR
  6. Ensure the availability of BPR and filled upto the stage.
  7. Check the carton , Lable and shipper specimen for its Batch No., Mfg date, Exp date, price etc.
  8. Check the cleaning of cartonator Machine.
  9. Ensure the filling quantity of the bottle.
  10. Ensure the REJECTED LABELED container is available for rejected bottles.

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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