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SOP on line clearance

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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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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