Line Clearance SOP

SOP for line clearance | line clearance in pharmaceutical industry |

• line clearance SOP covers below points:
  • line clearance definition
  • Purpose of line clearance
  • Preparation of Line clearance
  • General check points for processing area – line clearance checklist
  • Line clearance checklist for Dispensing Area
  • Line Clearance checklist for Production Area
  • Line Clearance checklist for Packing Area

1.0 OBJECTIVE :

• To ensure that the area and equipment, required for the manufacturing and packing activities of pharmaceutical products are free from any potential sources of cross contamination / mix-ups.

2.0 SCOPE :

• This procedure is applicable to all the activities including dispensing, manufacturing, packing and related activities.

3.0 RESPONSIBILITY :

• Officer/ Executive of respective department
• IPQA Chemist/ officer

4.0 ACCOUNTABILITY:

• Department Head
• Quality Assurance Head

5.0 PROCEDURE :

Line clearance is checking and verification process which provides a high degree of confidence or assurance that the said line or area is free from any unwanted residue or left over of previous processing’s before proceeding for next process.

Quality assurance has to grant Line clearance before the start of any activity whether it is batch to batch, product to product or activity after maintenance work.

5.1 Preparation of Line clearance :

• Line clearance is taken first by respective department people. Once the respective department people are satisfied with the line clearance, Quality Assurance staff are requested to verify and clear line/ area. This is documented in respective BMR/BPR.
• It is activity to avoid any inadvertent mixup/contamination of any left over residue of previous batch/product.

5.2 Take line clearance during Dispensing, Manufacturing, Packaging etc for the stages where any processing is to be started.

5.3 General check points for processing area:

• Use proper gowning procedure and safety appliances by personnel working in respective area.
• Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
• Ensure status board/ status label is updated.
• Ensure “CLEANED AND READY FOR USE” label is affixed on each cleaned equipment, tools, balances, bins etc.
• Ensure that the drain is cleaned as per SOP.
• Ensure that preventive maintenance of machines is carried out as per schedule.
• Check the cleanliness of supply air grills & return air grills of RLAF.
• Check the cleanliness of floor, RLAF walls, light fixtures, containers, tools and balances etc.
• Check the calibration of balances.
• Monitor & verify Temperature and Relative Humidity using hygrometer.
• Check the differential pressure across area must be within limits.
• Check the log book for updated upto entry of last activity.
• Check the approval status of the sample from Quality Control chemist or above after rinse / swab testing and attach the report with BMR/BPR.
• If all the general check point mentioned above are satisfactory, respective department shall sign in BMR / BPR.

5.4 Line clearance – Dispensing Area

• Check the Reverse Laminar Air Flow (RLAF) is `ON` for at least 15 minutes before starting dispensing.
• Check the status of all materials required for dispensing are readily available and are approved by Quality Control Head or his/her Designee.

5.5 Line Clearance – Production Area

• Granulation / Blending:
  • Verify that the BMR is updated upto Dispensing stage.
  • Verify the mesh size of sieve .
  • Verify yield of lubricated Granules (Blend).
• Compression / Encapsulation
  • Ensure that the Blend granules are Approved from Quality Control Department for compression/encapsulation.
  • Verify that the BMR is updated up to Blending stage.
  • Check the engraving matter and appearance in tablets and in polishing in capsules.
  • Check the Calibration status of IPQA balance and other measuring instruments.
  • Verify practical yield of compressed tablets and inspected good capsules.
• Coating
  • Ensure that the compressed tablets are Approved from Quality Control Department for coating.
  • Check the BMR is updated upto compression stage.
  • Check the Calibration status of IPQA balance and other measuring instruments.
  • Verify appearance of coated tablets through visual inspection.
• Tablet Printing
  • Check the printing quality and specification mentioned in BMR.
• Packing
  • Primary packing
    • Blister/Strip/Alu-Alu  packaging:
      • Check and verify the over- printing details on Aluminum foil.
      • Check the empty blisters /strip/alu-alu embossing details on Aluminum foil, i.e., Batch No, Manufacturing  Date, Expiry Date.
      • Check the leak test.
  • Secondary packing
    • Carton overprinting area:
      • Check and verify the overprinted detail on cartons, and label of corrugated boxes.

 6.0 ABBREVIATIONS:

Abbreviation	Expanded form
SOP	Standard Operating Procedure
BMR	Batch Manufacturing Record
BPR	Batch Packing Record
IPQA	In Process Quality Assurance
RLAF	Reverse Laminar Air Flow

7.0 ANNEXURES:

Nil

8.0 SOP REFERENCES

•  GMP Guidelines

END OF THE SOP

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