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SOP For Line Clearance

SOP For 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.
  • 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
  • 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)

 

PREVENTIVE MAINTENANCE OF PRODUCTION EQUIPMENT

 

 

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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