line clearance
- Objective:
To lay down the procedure for line clearance of manufacturing and warehouse area. 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), production (Injection), and warehouse areas of Formulation plant of Pharmaceutical company.
- Responsibility:
- Operator/Supervisor shall be responsible for proper cleaning of equipment /area
- Production Chemist/ Officer shall be responsible for checking the cleanliness of the area/equipment.
- IPQA Officer shall be responsible for giving Line Clearance.
- Accountability:
- Head-Q.A.
Preventing product mix-ups and cross-contamination
- Procedure:
- After area is checked and found appropriate by production personnel they should intimate the IPQA personnel for Line Clearance.
- After getting the intimation form production, IPQA person should ensure following points.
- Ensure the cleaning of entire area and equipment after every product/batch changeover as per their respective SOP.
- Ensure that the area cleaning should be done as mentioned in the SOP for cleaning of the respective area.
- Ensure that there are no traces of labels, powder/material of the previous product.
- Ensure the removal of all the documents/materials not required for the planned process.
- Ensure the room temperature and relative humidity is as per specified limit.
- Ensure the room differential pressure is as per specified limit.
- Ensure that riser filters are cleaned after every product changeover.
- After cleaning of the area and equipment ensure visually that the cleaning is appropriate
- Cleaning shall be checked by the officer of the concern department and IPQA personnel shall verify.
- In case 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 give the line clearance as per BMR & BPR and simultaneously sign in the BMR & BPR
- In case swab report has failed, re-perform the cleaning and analysis till cleaning is satisfactory.
- After verification of all required check points, IPQA personnel shall give the line
- If there is breakdown of more than half Hour in between any process of oral production, then the line clearance should be taken again
In-process Checks For Primary Packaging
- List of Annexure / Format:
| S.
No. |
Format Title | Format
Number |
Annexure
Number |
No. of Pages |
| 1 | Line Clearance check list for dispensing | |||
| 2 | Line clearance check list for Granulation | |||
| 3 | Line clearance check list for compression | |||
| 4 | Line clearance check list for coating |
| 5 | Line clearance check list for packing Cubical (Tablet & Capsule) | |||
| 6 | Line clearance check list for Packing Line | |||
|
7 |
Line clearance check list for Dry Syrup filling line | |||
| 8 | Line clearance check list for Dry Syrup packing line |
- References (if any)
-
- SOP on SOP’s
- Reason for Revision:
- New SOP
- Abbreviation and Definition
- IPQA : In process Quality Assurance
- QC : Quality Control
- BMR : Batch Manufactured Record
- BPR : Batch Packing Record
- SOP : Standard Operating Procedure
- QA : Quality Assurance
END OF SOP
Line Clearance Checklist for DISPENSING
| 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 & “CLEANED” label attached to the equipment | |||
| 2. | Ensure the area is free from previous product and unwanted materials | |||
| 3. | Ensure the temperature and relative humidity are within the specified limit | |||
| 4. | Ensure the differential pressure of the area is within specified limit | |||
| 5. | Check the proper gowning of personnel | |||
| 6. | Check the present status of label which shows the detail of activity | |||
| 7. | Ensure that RLAF is working properly | |||
| 8. | Ensure that the weighing balances are calibrated | |||
| 9. | Check the raw material / packing material for name ,material codes, appearance, A.R. No., Expiry/retest date etc. | |||
| 10. | Ensure the cleanliness of the container in which the dispensed material is to be kept. | |||
| 11. | Ensure that the riser filters are cleaned after every product changeover. |
Remarks (if any)
Checked By (sign/ date): Verified By (sign/ date):
(Production) (IPQA)
LINE CLEARANCE CHECKLIST FOR GRANULATION
| 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 & “CLEANED” label attached to the equipment. | |||
| 2. | Ensure the area is free from previous product and unwanted materials. | |||
| 3. | Ensure the temperature and relative humidity are within the specified limit | |||
| 4. | Ensure the differential pressure of the area is within the specified limit. | |||
| 5. | Check the proper gowning of personnel. | |||
| 6. | Check the present status label which shows the detail of activity. | |||
| 7. | Ensure the swab analysis of equipment to be used has passed. | |||
| 8. | Ensure that the weighing balance is calibrated and verify the weight of dispensed materials. | |||
| 9. | Ensure the availability of BMR | |||
| 10. | Ensure that the riser filters are cleaned after every product changeover. | |||
| 11. | Check the integrity of sieves. |
Remarks (if any)
Checked By (sign/ date): Verified By (sign/ date):
(Production) (IPQA)
LINE CLEARANCE CHECKLIST FOR COMPRESSION
| 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 & “CLEANED” label attached to the equipment. | |||
| 2. | Ensure the area is free from previous product and unwanted materials. | |||
| 3. | Ensure the temperature and relative humidity are within the specified limit. | |||
| 4. | Ensure the differential pressure of the area is within the specified limit. | |||
| 5. | Check the proper gowning of personnel. | |||
| 6. | Ensure the swab analysis of equipment to be used has passed. | |||
| 7. | Check the present status label which shows the detail of activity. | |||
| 8. | Ensure the blend analysis report is passing. | |||
| 9. | Ensure the availability of BMR and filled upto previous stage. | |||
| 10. | Verify the specified Dies and punches. | |||
| 11. | Ensure riser filters are cleaned after every product changeover. | |||
| 12. | Ensure that the weighing balances are calibrated. |
Remarks (if any)
Checked By (sign/ date): Verified By (Sign/ date):
(Production) (IPQA)
LINE CLEARANCE CHECKLIST FOR COATING
| 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 & “CLEANED” label attached to the equipment. | |||
| 2. | Ensure the area is free from previous product and unwanted materials. | |||
| 3. | Ensure the temperature and relative humidity are within the specified limit | |||
| 4. | Ensure the differential pressure of the area is within specified limit. | |||
| 5. | Check the proper gowning of personnel. | |||
| 6. | Ensure the swab analysis of equipment to be used has passed. | |||
| 7. | Check the present status label which shows the detail of activity. | |||
| 8. | Ensure the core tablet analysis report is passing | |||
| 9. | Ensure the availability of BMR and filled upto previous stage. | |||
| 10. | Ensure riser filters are cleaned after every product changeover. | |||
| 11. | Ensure that the equipment Log book is filled upto previous stage. |
Remarks (if any)
Checked By (sign/ date): Verified By (Sign/ date):
(Production) (IPQA)
LINE CLEARANCE CHECKLIST FOR PACKING CUBICAL (Tablet and Capsule)
| 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 & “CLEANED” label attached to the equipment. | |||
| 2. | Check the area is free from previous product and unwanted materials. | |||
| 3. | Ensure the temperature and relative humidity are within the specified limit | |||
| 4. | Ensure the differential pressure of the area is within specified limit. | |||
| 5. | Check the proper gowning of personnel. | |||
| 6. | Check the present status label which shows the details of activity. | |||
| 7. | Verify the issued primary packaging material with respect to BPR. | |||
| 8. | Check the previous product stereos are destroyed. | |||
| 9. | Ensure the swab analysis of equipment to be used has passed. | |||
| 10. | Check the foil specimen for its Batch No., Mfg. Date, Exp. date , M.R.P etc. | |||
| 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. |
Remarks (if any)
Checked By (sign/ date): Verified By (Sign/ date):
(Production) (IPQA)
LINE CLEARANCE CHECKLIST FOR PACKING LINE
| 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 & “CLEANED” label attached to the equipment. | |||
| 2. | Check the area is free from previous product and unwanted materials. | |||
| 3. | Ensure the temperature is within the specified limit | |||
| 4. | Check the present status label which shows the details of ongoing activity. | |||
| 5. | Verify the issued secondary and tertiary packaging material with respect to BPR. | |||
| 6. | Ensure the availability of BPR and filled up to previous stage. | |||
| 7. | Check the carton, outer, label and shipper coding for its Batch No., Mfg. date, Exp. date, M.R.P. etc. | |||
| 8. | Ensure the conveyor belt is free from any previous product and unwanted material. | |||
| 9. | Ensure that the coded secondary packing materials are kept in cleaned plastic carats with status label attached. | |||
| 10. | Ensure the REJECTED LABELED container is available for rejected strip/blister | |||
| 11. | Ensure that the weighing balances are calibrated. | |||
| 12. | Check and ensure carton weighing range slip placed near weighing balance. |
Remarks (if any)
Checked By (sign/ date): Verified By (Sign/ date):
(Production) (IPQA)
LINE CLEARANCE CHECKLIST FOR DRY SYRUP FILLING LINE
| 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 & “CLEANED” label attached to the equipment. | |||
| 2. | Check the proper gowning of personnel. | |||
| 3. | Check the area is free from previous product and unwanted materials. | |||
| 4. | Ensure the temperature and relative humidity is within the specified limit | |||
| 5. | Check the present status label which shows the details of ongoing activity. | |||
| 6. | Ensure that the weighing balances are calibrated. | |||
| 7. | Ensure the differential pressure is within the specified limit. | |||
| 8. | Ensure the swab analysis of equipment to be used has passed. | |||
| 9. | Ensure the availability of BMR filled up to previous stage. | |||
| 10. | Ensure the blend analysis report has passed. | |||
| 11. | Ensure riser filters are cleaned after every product changeover. | |||
| 12. | Ensure that the equipment Logbook is filled up to previous stage. |
Remarks (if any)
Checked By (sign/ date): Verified By (Sign/ date):
(Production) (IPQA)
LINE CLEARANCE CHECKLIST FOR DRY SYRUP PACKING LINE
| 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 & “CLEANED” label attached to the equipment. | |||
| 2. | Check the area is free from previous product and unwanted materials. | |||
| 3. | Check the present status label which shows the details of ongoing activity. | |||
| 4. | Verify the issued secondary packaging material with respect to BPR. | |||
| 5. | Ensure the availability of BPR and filled up to previous stage. | |||
| 6. | Check the carton, outer, label and shipper coding for its Batch No., Mfg. date, Exp. date, M.R.P. etc. | |||
| 7. | Ensure that the equipment Log book is filled up to previous stage. | |||
| 8. | Ensure that the coded secondary packing materials are kept in cleaned plastic carats with status label attached. | |||
| 9. | Ensure the REJECTED LABELED container is available for rejected bottles / labels / outers / cartons. | |||
| 10. | Ensure that the weighing balances are calibrated. |
Remarks (if any)
Checked By (sign/ date): Verified By (Sign/ date):
(Production) (IPQA)
