Purpose
To lay down the procedure for the line clearance before
starting the activity in Dispensing, Manufacturing, Filling & Packing Area.
Procedure
Line clearance is the system assuring equipment and
workstation are clean and free from any material, product, product residues and
documents which is not required for current operation and the area is ready for
required operation to avoid cross contamination.
All line clearance checks shall be performed before
start of activity in the process area.
Ensure the line clearance operations after
product/batch change over, before starting of next product/batch.
Line clearance of
Dispensing/manufacturing/Filling/Packing area shall be done as per checklist
given in BMR/BPR.
Line Clearance in the
Dispensing Area
- Ensure that gowning procedure is followed.
- Ensure that area cleaning has been done as mentioned in the SOP for cleaning of the area.
- Ensure the cleanness of waste bin.
- Ensure the removal of all previous product documents/materials and labels should not be present in the area.
- Ensure that the return air riser filters and pre-filters of RLAF are cleaned and status label is affixed
- Ensure that HVAC system is functional & environmental condition are within limit.
- Ensure that differential pressure of dispensing area is within limit and record is updated.
- Ensure that the RLAF & utensils are cleaned & ‘’CLEANED’’ status label is fixed on all the equipment’s/utensils.
- Ensure that the balances are cleaned & calibrated and calibration record is available & calibration tag is affixed.
- Ensure that the containers used for dispensing are clean & “CLEANED” status label is affixed.
- Ensure that pressure differential of RLAF across HEPA & pre filter is within limit.
- Ensure that preventive maintenance of RLAF has been carried out as per the schedule.
- Ensure the completeness of logbooks.
- Warehouse Personnel shall ensure the compliance of above mentioned points in the dispensing area and inform to QA personnel, QA personnel shall verify the same and give
- the line clearance.
Line Clearance in the
Manufacturing Area
- Gowning procedure is followed.
- Ensure that area cleaning has been done as mentioned in the SOP for cleaning of the area.
- Ensure that all equipment is clean and ‘’CLEANED’’ status label is affixed).
- Ensure that the drain is cleaned.
- Ensure the removal of all previous product documents/materials and labels should not be present in the area.
- Ensure that the return air riser filters are cleaned and status label is.
- Ensure that HVAC system is functional & environmental condition are within limit i.e. Temp. NMT 25°C & RH NMT 55%.
- Ensure that differential pressure of manufacturing area is within limit and record is updated.
- Ensure that the balances are cleaned & calibrated and calibration record is available & calibration tag is affixed.
- Ensure that preventive maintenance of machine has been carried out as per the schedule.
- Ensure that Raw material required for the batch are taken in the manufacturing area.
- Ensure the completeness of logbooks and records.
- Production personnel shall ensure the compliance of above mentioned points in the manufacturing area and inform to QA personnel, QA personnel shall verify the same and give the line clearance.
- Note: in case of bulk hold in bulk holding vessel, area shall be considered cleaned for
- next product.
Line Clearance in the Filling
Area
- Gowning procedure is followed.
- Ensure that area cleaning has been done as mentioned in the SOP for cleaning of the area.
- Ensure that previous product BPR is removed from the area.
- Ensure that HVAC system is functional & environmental condition are within limit i.e. and record is updated.
- Ensure that differential pressure of Filling area is within limit and record is updated.
- Ensure that all equipment is cleaned and ‘’CLEANED’’ status label is affixed.
- Ensure completeness of logbooks & records.
- Ensure that the propellant valves of propellant charging machine shall be closed.
- Production personnel shall ensure the compliance of above mentioned points in the manufacturing area and inform to QA personnel, QA personnel shall verify the same and give the line clearance.
- LPG odor evaluation test shall be performed on daily basis before line clearance by production and IPQA personal and the sample taken for evaluation shall be retained for 30 days.
Line Clearance in the Packing
Area
- Gowning procedure is followed
- Ensure that area cleaning has been done as mentioned in the SOP for cleaning of the area.
- Ensure that HVAC system is functional & environmental condition are within limit and record is
- updated.
- Ensure that differential pressure of Packing area is within limit and record is updated.
- Ensure the completeness of logbooks & records.
- All stages of the BPR is filled and completed up to the previous stage.
- Ensure that secondary packing materials required for the batch are issued by the warehouse and record updated in the BPR.
- Ensure that the machines/equipment’s are cleaned and ‘’CLEANED’’ status label is fixed.
- Line clearance shall be done by Production personnel in packing area, checked & signed by Executive/Designee-PRD and verified & signed by QA.
Re-line clearance
- In case of below mentioned points re-line clearance shall be done through additional pages of respective BMR/BPR.
- If re-line clearance required for any reason like as re-sampling, after breakdown, additional material dispensing etc. than the line clearance shall be taken.
- If the machine/activity stopped for more than 24 hrs. then fresh line clearance shall be taken before starting the operation, then line clearance shall be taken.
- In case of post line clearance of the area, any maintenance work is performed and maintenance activity is done for product contact parts or major maintenance activity when product has been taken out from the area, after the completion of the maintenance work and cleaning, line clearance for the same shall be taken again from QA personnel.
Critical Check Points During
Line Clearance, Ensure the following:
Cleanliness
of floor
Cleanliness
of walls
Cleanliness
of drain
Cleanliness
of Container (if applicable)
Cleanliness
of Tools, Waste bin, Light Fixture
Ensure
cleanliness of air grills(Supply/Return)
Ensure
the cleanliness of all equipment and their surroundings.
Area
under machine/Equipment
Status
labelling
Availability
of gloves and masks
Online
documentation
Balance
calibration & verification
Material
status
