SOP on line clearance
Objective:
To lay down the procedure for line clearance of manufacturing, warehouse . This is to ensure that the start up of any production/ process is free from previous material/contaminants.
Scope:
This SOP is applicable for line clearance of production (oral), warehouse areas of Formulation plant.
Responsibility:
Operator/ Supervisor shall be responsible for proper cleaning of equipment and area.
Production Chemist/ Officer shall be responsible for checking the cleanliness of the area and equipment.
IPQA Officer shall be responsible for giving Line Clearance.
Accountability:
Head-Q.A.
Procedure:
After area is checked and found appropriate by warehouse/production personnel they should intimate IPQA personnel for Line Clearance.
After getting the intimation form production/pilot plant, IPQA person should check the area, equipment and documents as per respective line clearance checklist and give line clearance.
While line clearance if any point not found satisfactory as per line clearance checklist, warehouse/production personnel shall comply it and again intimate the IPQA personnel for Line Clearance.
If there is any previous product traces, re-perform the cleaning procedure unless the area/equipment is cleaned properly.
After proper cleaning of equipments/ area, production personnel shall intimate to IPQA personnel along with intimation slip for collection of swab / rinse sample, if required.
After receipt of the swab/ rinse report from QC department as approved, IPQA personnel shall verify the report and verification of all required check points and give the line clearance as per BMR & BPR and simultaneously sign in the BMR & BPR.
If there is breakdown of more than ½ Hr. in between any process, then the line clearance should be taken again.
There is no need to attach additional line clearance sheet for carry forward line clearance due to shift or date change.
List of Annexure
Line Clearance check list for dispensing
Line clearance check list for Manufacturing
Line clearance check list for primary packing
Line clearance check list for secondary packing
Reason for Revision:
New SOP
Abbreviation and Definition
IPQA: In-process Quality Assurance
BMR: Batch Manufacturing Record
BPR: Batch Packing Record
SOP: Standard Operating Procedure
QA: Quality Assurance
Annexure – I
Line Clearance checklist for DISPENSING
- Product:
- Batch No. :
- Previous Product:
- Batch No. :
- Area:
- Date :
| Sr. No. | Check List |
| 1. | Check and ensure that the area and equipment are visually clean. |
| 2. | “CLEANED” label attached to the equipment |
| 3. | Ensure the area is free from previous products and unwanted materials |
| 4. | Ensure the temperature and relative humidity are within the specified limit |
| 5. | Ensure the differential pressure of the area is within the specified limit |
| 6. | Check the proper gowning of personnel |
| 7. | Check the present status of a label that shows the detail of the activity |
| 8. | Ensure that RLAF is working properly |
| 9. | Ensure that the weighing balances are calibrated |
| 10. | Check the required material for name, material codes, appearance, A.R. No., Expiry, retest date, etc. |
| 11. | Ensure the cleanliness of the container in which the dispensed material is to be kept. |
| 12. | Ensure that the riser filters are cleaned after every product changeover. |
| 13. | Ensure that the preventive maintenance has been done as per plan. |
LINE CLEARANCE CHECKLIST FOR MANUFACTURING
#Stage: Granulation / Compression / Dry Syrup filling /Capsule filling / Coating / Tablet inspection
- Product:
- Batch No. :
- Previous Product:
- Batch No. :
- Area:
- Date :
| Sr.No. | Check List |
| 1. | Check and ensure that the area and equipment are visually clean. |
| 2. | “CLEANED” label attached to the equipment. |
| 3. | Ensure the area is free from previous products and unwanted materials. |
| 4. | Ensure the temperature and relative humidity are within the specified limit |
| 5. | Ensure the differential pressure of the area is within the specified limit. |
| 6. | Check the proper gowning of personnel. |
| 7. | Check the present status label which shows the details of ongoing activity. |
| 8. | Ensure the rinse/swab analysis of the equipment to be used has passed. |
| 9. | Ensure that the weighing balances are calibrated. |
| 10. | Ensure the availability of BMR and filled up to the previous stage. |
| 11. | Verify the dispensed |
| 12. | #Check the integrity of the sieves/screen. |
| 13. | #Ensure the blend/core tablets analysis report has passed. |
| 14. | Verify the specified Dies, punches, or change parts. |
| 15. | Verify the dispensed EHG capsule shells. |
| 16. | Ensure that the riser filters are cleaned after every product changeover. |
| 17. | Ensure that the preventive maintenance has been done as per plan. |
| 18. | Ensure that the equipment Logbook is filled up to the previous stage. |
| 19. | Ensure all change parts to be used with equipment should be clean before assembling. |
LINE CLEARANCE CHECKLIST FOR PRIMARY PACKING
- Product:
- Batch No. :
- Previous Product:
- Batch No. :
- Area:
- Date :
| Sr. No. | Check List |
| 1. | Check and ensure that the area /equipment is visually clean. |
| 2. | “CLEANED” label attached to the equipment. |
| 3. | Check the area is free from previous products and unwanted materials. |
| 4. | Ensure the temperature and relative humidity are within the specified limit |
| 5. | Ensure the differential pressure of the area is within the specified limit. |
| 6. | Check the proper gowning of personnel. |
| 7. | Check the present status label which shows the details of the activity. |
| 8. | Verify the issued primary packaging material with respect to BPR. |
| 9. | Check the previous product stereos are destroyed. |
| 10. | Ensure the swab analysis of the equipment to be used has passed. |
| 11. | Check the availability of BPR and filled up to the previous stage. |
| 12. | #Ensure the core tablet / coated tablet/capsule analysis report has passed. |
| 13. | #Ensure that the tablet/capsule to be packed is contained in a closed container and is labeled as “APPROVED”. |
| 14. | Ensure that the equipment Logbook is filled up to the previous stage. |
| 15. | Ensure that the weighing balance is calibrated. |
| 16. | Ensure that the preventive maintenance has been done as per plan. |
| 17. | Ensure all change parts to be used with equipment should be clean before assembling. |
LINE CLEARANCE CHECKLIST FOR SECONDARY PACKING
- Product:
- Batch No. :
- Previous Product:
- Batch No. :
- Area:
- Date :
| Sr. No. | Check List |
| 1. | Check and ensure that the area/equipment are visually clean. |
| 2. | “CLEANED” label attached to the equipment. |
| 3. | Check the area is free from previous products and unwanted materials. |
| 4. | Ensure the temperature is within the specified limit |
| 5. | Check the present status label which shows the details of ongoing activity. |
| 6. | Verify the issued secondary and tertiary packaging material with respect to BPR. |
| 7. | Ensure the availability of BPR and filled up to the previous stage. |
| 8. | Check the carton, outer, label, and shipper coding for its Batch No., Mfg. date, Exp. date, M.R.P. etc. |
| 9. | Ensure the equipment are free from any previous product and unwanted material. |
| 10. | Ensure that the coded secondary packing materials are kept in cleaned plastic carats with a status label attached. |
| 11. | #Ensure the REJECTED LABELED container is available for rejected strips/blisters/ bottles/ labels/ cartons and other packing materials |
| 12. | Ensure that the weighing balances are calibrated. |
| 13. | Check and ensure the carton weighing range slip is placed near the weighing balance. |
| 14. | Ensure that the equipment Logbook is filled up to the previous stage. |
| 15. | Ensure that the preventive maintenance has been done as per plan. |
# Strike off which is not applicable.
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