Line clearance procedure

1. On request from concerned area for line clearance, QA will Check all the points/line & shall
ensure the type of cleaning (Product to Product or Batch to Batch). If the machine/Area having Product to
Product cleaning, then ensure the machine is in dismantling condition and check for absence of previous
product/material in each dismantled parts of the machine.
2. After complete verification of equipment at dismantled condition from IPQA checklist as
well as respective documents like batch records to be signed, then production person shall go for
assembling of equipment as per the plan.
3. Once the equipment line clearance is done, the equipment can be used up to its cleaning
validity only, if it crosses the validity date, then re-line clearance of equipment shall be done
4. Check and ensure that the previous product/ batch materials and status labels are removed
from the area.
5. Ensure that dustbins in the area are emptied out and do not carry debris of previous product /
batch.
6. Check the ceiling, floor, walls, windows and door frames and electrical panels in the area are
clean and free from visible traces of previous product/ batch. (Where ever applicable).
7. Ensure cleanliness of Drain point provided in the area
8. Ensure cleanliness of pendants, dust extraction hose are cleaned
9. Ensure cleanliness of Weighing balance platform and Display of balance
10. Ensure that the cleaning record for the area is updated.
11. Ensure calibration status of all pressure gauges, balances and timers are updated
12. Check that the documents pertaining to the previous product are removed from the area.
13. Check that the equipment log sheets of all machines in the area are complete as on date with
cleaning details.
14. Ensure that environment conditions (Temperature & RH) record is updated.
15. Ensure that the Batch Manufacturing Record is complete in all respects up to the stage.
16. Line clearance for all equipments should be given as per check points mentioned in
checklists and for specific areas / Parts of machine shall be verified accordingly the photographs
available in checklist as well as in respective Operation and cleaning SOP’s of manufacturing
equipments.
17. Ensure that, the rejects of previous product are destroyed.
18. Ensure that the area and equipments are appropriately labelled for status
19. Ensure Batch manufacturing record & Batch Packing record are completed up to the
executed activity and verified.
20. Check that the machines have been cleaned as per respective SOP of respective department
for the removal of previous batch/ product.
21. The checking during line clearance should include all machine places where the product/
packaging material may get trapped. Use Additional flash light or compressed air if required to ensure
adequacy of cleanliness at critical parts/areas. 
22.  All excess / rejected packing materials of previous product shall be removed from the line.
23.   All used hand gloves, dusters of previous product shall be removed from the line
24. All stereos of the previous product shall be removed/ destroyed by cutting into pieces (as
applicable).
25. During line clearance of primary packing line and secondary packing line Quality Assurance
personnel shall checks the complete deletion of Pharmacode / Barcode of previous product on PLC/HMI
of Machine.
26. Check conveyor belt and area below the belt for absence of previous product.
27. Tools box checked for absence of previous product and Sorting tray checked for absence of
previous product.
28. Verify and ensure correctness of next product/ batch for label, Integrity, storage & other
appropriate parameters.
29. Individual line clearance checklist shall be done and checked by production for respective
equipments which shall be verified by Quality Assurance.
30. Production and Quality Assurance shall check & verify the specimen of Aluminium
foil,PVC, Carton, label etc before start of packing activity.
31. In case of dispensing of Raw & Packing material Quality assurance shall verify the release of
the same from Quality Control.
32. Potency Calculation of Raw material shall be checked by production & verify by Quality
Assurance.
33. Individual line clearance checklist shall be done and checked by production for respective
equipment which shall be verified by Quality Assurance.