Line Clearance SOP | How to do it properly?

Scope

This SOP is applicable to all stages of manufacturing operations carried out before the start of operation / stage, during the Dispensing / Manufacturing / Packing to avoid any contamination or mix ups of the previous product to the next product in the dispensing / manufacturing / 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 as per SOP No. PAL/HRD/O/002 (Current Version).

·         Ensure that area cleaning has been done as mentioned in the SOP for cleaning of the area.

·         Ensure the cleanliness of waste bin.

·         Ensure the removal of all previous product documents / materials and labels should not be present in the area.

·         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 dispensing area is within limit.

·         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.

·         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

·         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 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 affixed

·         Ensure that HVAC system is functional & environmental condition are within limit i.e. Temp. NMT 25 °C & RH NMT 55 % or as per area standard.

·         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.

·         Note:    in case of bulk hold / Store in bulk holding vessel, area shall be considered cleaned for next product.

Line Clearance in the Filling Area

·         Gowning procedure is followed.

·         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. Temp. NMT 25 °C & RH NMT 55 %.

·         Ensure that differential pressure of Filling area is within limit.

·         Ensure that all equipment is cleaned and ‘’CLEANED’’ status label is affixed

·         Ensure that the valves of filing charging machine shall be closed.

·         LPG odor evaluation test shall be performed on daily basis before line clearance by QA personal as per given checklist.

Line Clearance in the Packing Area at FRD

·         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 i.e. Temp. NMT 25 °C & RH NMT 55 %.

·         Ensure that differential pressure of Packing area is within limit and record is updated.

·         Ensure the completeness of logbooks.

·         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 FRD personnel in packing area, checked & signed by Executive / Designee-FRD and verified & signed by QA.

·         All safety parameter to be ensured at every stage of line clearance.