Line Clearance

To ensure that the area and equipment to be used for dispensing of raw and packing materials, manufacturing and packaging of finished products are free from leftovers of previous product/ batch/ material.

This procedure is applicable for conducting the line clearance at the dispensing, manufacturing, packaging area & process equipments.

Precautions: Ensure that a Batch manufacturing/ packing starts only after the line clearance is approved by both Production and IPQA personnel.

General Instructions
On request from the concerned personnel from the dispensing, manufacturing or packaging area for line clearance, check the following points that are source of contamination/ mix-up.

Check and ensure that the status labels of previous product are removed.

Ensure that room/equipment is cleaned as per respective SOP and the ‘Cleaned’ status label for area / equipment is affixed with all relevant details.

Ensure that the equipment cleaning is recorded in the respective log books and checklists are completed and signed by relevant personnel.

Check and ensure that all materials like utensil, tools, container, documents etc. (used in the previous product) are removed from the area.

Ensure that the environmental condition of the area is maintained as required by the respective BMR/BPR and relevant entries are recorded.

Check the cleanliness of balance(s) and ensure the calibration status and daily function check before use. Ensure that record(s) are completed in the respective log books by reviewing them.

Check that the BMR/BPR is updated till the current stage/time.

Check that the issued materials bear the ‘Released’ labels of QC.

Ensure that the software setting parameter entered in PLC (Programmable Logical Control) for the previous batch/product is closed and is clear for the next batch setting.

Ensure that the cleaning of the area/equipment (Type A and Type B) is not exceeding the validity period as per the relevant production SOP by checking details on label affixed

If all above requirements are satisfactory, then production and IPQA personnel shall sign on the respective area and equipment checklist, log books as well as in the defined place in respective BMR/BPR.

In case of any failure to comply the line clearance, address the situation with a deviation/incident (SOP No.: QA/008, QA/062) as appropriate.

After taking the corrective action, review the line clearance once again and sign the area checklist and BMR/BPR if all requirements are found satisfactory.

Dispensing
Check that the temperature, relative humidity and differential pressure of the area is suitable for dispensing.

Ensure that Laminar Air Flow (LAF) bench of dispensing booth is started at least 30 minutes before the start of the operation.

In case of MDI product, ensure that all raw materials and packaging materials have been acclimatized for at least 12 hours before start of dispensing.

Check the dispensing area with respect to its cleanliness and cleaning status of required equipments (Scoops etc).

Check the calibration status label of the balance(s) and qualification status label of booth. Check that bubble point of the balance (s) is in the center position.

Check the product name, product code, batch no., batch size, manufacturing and expiry date in the Batch Production Record. Ensure that same details are maintained on the status label.

Ensure the Analytical Report No. (AR No.), sampling date, mfg. date, exp. date and retest date are available on the ‘Released’ label of raw materials.

Ensure the availability of required quantity of API and excipients to be dispensed for the batch with the %Assay and %LOD of API with corresponding AR. No.

Check that materials are from the approved sources that are intended for the product.

Ensure that approved SOPs and Work instructions are being followed.

Sign in the space provided for the line clearance in the Batch Production Record, area check list and cleaning log book after confirming that all requirements of check list for dispensing have been fulfilled.

Granulation / Product Concentrate Preparation
Check that the temperature, relative humidity and differential pressure of the area is suitable for the process to be initiated.

Check the granulation area with respect to its cleanliness and cleaning status of equipments including mixer, oscillator, granulator, fluid bed dryer, etc.

Check the calibration status label on balance and qualification status label of the equipment.

Ensure that the bubble point of the balance (s) is in the center position.

In case of MDI products, check the cleanliness of mixing vessel and ensure that the chiller temperature is within required range.

Check that all ingredients are present and are identified properly with reference to the Dispensing Label (FRM No.: FPG/027) and are signed by both production and IPQA personnel.

Ensure that all approved SOPs and work instructions are being followed.

Sign in the space provided for line clearance in the Batch Production Record, area and equipment check list and cleaning log book after confirming that all requirements of check list for granulation, product concentrate preparation process have been fulfilled.

Blending
Check that the product containers, materials, status labels, BMR of previous operation are removed.

Check that the area along with the respective equipment is cleaned as per the cleaning procedure and records are updated and within validity period of production SOP.

Check that the temperature, relative humidity and differential pressure of the area is suitable for the process to be initiated.

Check qualification status label of the blender.

Ensure that approved SOPs and Work instructions are being followed.

Check that BMR is updated till the current stage.

Sign in the space provided for line clearance in the Batch Production Record, area and equipment check list and cleaning log book after confirming that all requirements of check list for blending process have been fulfilled.

Compression / Encapsulation / Filling
Check that the temperature, relative humidity and differential pressure of the area is suitable for the process to be initiated.

Check the calibration status label of balance and qualification status label of the equipment.

Ensure that the bubble point of the balance (s) is in the center position.

In case of MDI products, ensure that
i. The specified primary packing materials are acclimatized for at least 12 hours, before start of filling.

ii. Laminar Air Flow (LAF) bench of filling area is started at least 30 minutes, before start of filling operation.

iii. The trace amount of product concentrate of the previous batch is discarded and equipment bears ‘Cleaned’ status label.

Check the area with respect to its cleanliness and cleaning status of equipments (compression machine, tablet deduster, metal detector, hopper, feeder, encapsulation machine, product filling, propellant filling and crimper).

Ensure that only cleaned bins, containers and quarantine SS cabinets are used during operation.

Ensure that approved SOPs and work instructions are being followed.

Sign in the space provided for line clearance in the Batch Production Record, area and equipment check list and cleaning log book after confirming that all requirements of check list for compression, encapsulation, filling process have been fulfilled.

Coating
Check that the temperature, relative humidity and differential pressure of coating area is suitable for process to be initiated.

Check the calibration status label of balance and qualification status label of the equipment.

Ensure that the bubble point of the balance(s) is in the center position.

Ensure that appropriate coating materials are dispensed and are being used for the batch.

Check the coating area with respect to its cleanliness and cleaning status of required equipments (coating pan, containers, exhaust duct, hot air supply and compressed air filter).

Ensure that the correct batch as per the BMR/BPR with appropriate storage bins/ containers are brought for coating and all of them are approved by QA.

Ensure that approved SOP and Work instructions are being followed.

Sign in the space provided for line clearance in the Batch Production Record, area and equipment checklist and cleaning log book after confirming that all requirements of check list for coating process have been fulfilled.

Inspection
Check that the temperature, relative humidity and differential pressure of inspection area is suitable for process to be initiated.

Check the inspection area with respect to its cleanliness and ensure that it is free from any leftovers of the previous product.

Ensure that only cleaned bins or containers are used during operation.

Ensure that approved SOP and Work instructions are being followed.

Sign in the space provided for line clearance in the Batch Production Record, area check list and cleaning log book after confirming that all requirements of check list for inspection process have been fulfilled.

Primary Packing
Check that the temperature, relative humidity and differential pressure of primary packing area is suitable for the process to be initiated.

Check the qualification status label of the equipment.

Ensure that the primary packing area is free from any leftovers of the previous product.

Ensure that appropriate primary packing materials (PVC/PVDC foil, aluminum foil, HDPE bottle etc.) are dispensed and are being used for the batch by matching the packing materials item code with those mentioned in the primary BPR. Sign on the sample of top foil for Alu -PVC/PVDC packing and both top and bottom foil for Alu-Alu packing.

Ensure that only approved product bins/ containers are brought for primary packing and match details with BPR.

Check the physical appearance of tablets/capsules, PVC, PVDC and Aluminum foil.

Check that the machine is set according to the product batch no. and exp. date.

Check batch coding on blisters and sign on the blister marking proof in the primary BPR.

Ensure that approved SOP and Work instructions are being followed.

In case of MDI products, check the overprinting details on the can before initial weight check. Check the set value of weighing balance for initial weight check.

Sign in the space provided for line clearance in the Batch Production Record, area and equipment check list and cleaning log book after confirming that all requirements of check list for primary packaging have been fulfilled.

Secondary Packing
Check that the temperature and relative humidity of secondary packing area is suitable for the process to be initiated.

Ensure that the secondary packing area is free from any leftovers of the previous product.

Check the calibration status label of balance(s) and autocheckweigher and qualification status label of the equipment.

Check details on the secondary packaging material (inner carton, outer carton, label, leaflet and shipper) of the product and confirm that they are according to product specifications.

Check that the machine is set according to product batch no., mfg. and exp. date.

Check batch printing on inner carton/ outer carton, shipper and sign in the respective overprinting marking proof attached in the secondary BPR.

Check the batch no, manufacturing and expiry date of product being packaged and that being printed on packaging material.

Ensure that approved SOP and Work instructions are being followed.

In case of MDI products, ensure that a fourteen (14) days “Quarantine” period has been maintained before starting secondary packing.

For MDI products check the overprinting details on the label, inner carton and shipper. Check the set value of weighing balance for final weight check.

Sign in the space provided for line clearance in the Batch Production Record, area and equipment check list and cleaning log book after confirming that all the requirements of check list for secondary packaging have been fulfilled.

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