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 check list for DISPENSING
Product: | Batch No. : | ||
Previous Product: | Batch No. : | ||
Area: | Date : |
Sr. No. | Check List | Yes/ No/NA | Checked
By |
Checked
By |
Verified
By |
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 product 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 specified limit | ||||
6. | Check the proper gowning of personnel | ||||
7. | Check the present status of label which shows the detail of 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. |
Remarks (if any):
Checked By (sign/ date) Checked By (sign/ date) Verified By (sign/ date)
(Store) (Production) (IPQA)
LINE CLEARANCE CHECK LIST 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 | Yes/ No/ NA | Checked
By |
Verified
By |
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 product 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 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 equipment to be used has passed. | |||
9. | Ensure that the weighing balances are calibrated. | |||
10. | Ensure the availability of BMR and filled up to previous stage. | |||
11. | Verify the dispensed | |||
12. | #Check the integrity of 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 previous stage. | |||
19. | Ensure all change parts to be used with equipment should be clean before assembling. |
# Strike off which is not applicable.
Remarks (if any):
Checked By (sign/ date): Verified By (Sign/ date):
(Production) (IPQA)
LINE CLEARANCE CHECK LIST FOR PRIMARY PACKING
Product: | Batch No. : | ||
Previous Product: | Batch No. : | ||
Area: | Date : |
Sr. No. | Check List | Yes/No/ NA | Checked
By |
Verified
By |
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 product 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 specified limit. | |||
6. | Check the proper gowning of personnel. | |||
7. | Check the present status label which shows the details of 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 equipment to be used has passed. | |||
11. | Check the availability of BPR and filled up to previous stage. | |||
12. | #Ensure the core tablet / coated tablet / capsule analysis report has passed. | |||
13. | #Ensure that the tablet / capsule to be packed are contained in closed container and are labeled as “APPROVED”. | |||
14. | Ensure that the equipment Log book is filled up to 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 equipments should be clean before assembling. |
# Strike off which is not applicable.
Remarks (if any):
Checked By (sign/ date): Verified By (Sign/ date):
(Production) (IPQA)
LINE CLEARANCE CHECK LIST FOR SECONDARY PACKING
Product: | Batch No. : | ||
Previous Product: | Batch No. : | ||
Area: | Date : |
Sr. No. | Check List | Yes/No/ NA | Checked
By |
Verified
By |
1. | Check and ensure that the area/equipments are visually clean. | |||
2. | “CLEANED” label attached to the equipment. | |||
3. | Check the area is free from previous product 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 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 equipments are free from any previous product and unwanted material. | |||
10. | Ensure that the coded secondary packing materials are kept in cleaned plastic carats with status label attached. | |||
11. | #Ensure the REJECTED LABELED container is available for rejected strip/ blister/ bottles/ labels/ cartons and other packing materials | |||
12. | Ensure that the weighing balances are calibrated. | |||
13. | Check and ensure carton weighing range slip placed near weighing balance. | |||
14. | Ensure that the equipment Log book is filled up to previous stage. | |||
15. | Ensure that the preventive maintenance has been done as per plan. |
# Strike off which is not applicable.
Remarks (if any):
Checked By (sign/ date): Verified By (Sign/ date):
(Production) (IPQA)
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