Line Clearance Checklist for Dispensing
- Check and ensure that the area/ equipment are visually clean.
- Check the area is free from previous product and unwanted materials
- Ensure the temperature and relative humidity is within the specified limit as per mentioned in BMR.
- Check the differential pressure of the area is –ve with respect to the adjacent corridor.
- Check the proper gowning of personnel.
- Check the present status label which shows the detail of Activity.
- Ensure the RLAF is working properly.
- Ensure that the balance is calibrated.
- Check the raw material for the name, material codes, appearance, AR No., expiry/ retest date etc.
- Ensure the cleanness of the container in which dispensing is to be done.
Line Clearance Checklist for Granulation
- Check and ensure that the area/ equipment are visually clean.
- Check the area is free from previous product and unwanted materials
- Ensure the temperature and relative humidity is within the specified limit as per mentioned in BMR.
- Check the differential pressure of the area is –ve with respect to the adjacent corridor.
- Check the proper gowning of personnel.
- Check the present status label which shows the detail of the activity.
- Ensure that the balance is calibrated and verify the weight of dispensed materials
- Check the integrity of sieve and FBD bag.
- Ensure the availability of BMR
- Check the wash water analysis report.
Line Clearance Checklist for Compression
- Check and ensure that the area/ equipment are visually clean.
- Check the area is free from previous product and unwanted materials
- Ensure the temperature and relative humidity is within the specified limit as per mentioned in BMR.
- Check the differential pressure of the area is –ve with respect to the adjacent corridor.
- Check the proper gowning of personnel.
- Check the present status label which shows the detail of the activity.
- Check the wash water/ swab analysis report.
- Check the blend analysis report is passing.
- Ensure the availability of BMR and filled upto the stage.
- Ensure the correct dies and punches.
Line Clearance Checklist for Coating
- Check and ensure that the area/ equipment are visually clean.
- Check the area is free from previous product and unwanted materials
- Ensure the temperature and relative humidity is within the specified limit as per mentioned in BMR.
- Check the differential pressure of the area is –ve with respect to the adjacent corridor.
- Check the proper gowning of personnel.
- Check the present status label which shows the detail.
- Check the wash water/ swab analysis report.
- Check the core tablet analysis report.
- Ensure the availability of BMR and filled upto the stage.
Line Clearance Checklist for Packing Cubicles (Tablet & Capsule)
- Check and ensure that the area/ equipment are visually clean.
- Check the area is free from previous product and unwanted materials
- Ensure the temperature and relative humidity is within the specified limit as per mentioned in BPR.
- Check the differential pressure of the area is –ve with respect to the adjacent corridor.
- Check the proper gowning of personnel.
- Check the present status label which shows the details.
- Verify the issued primary packaging material with respect to BPR
- Check the previous product stereo are destroyed.
- Check the foil specimen for its Batch No., Mfg date, Exp date, price etc.
- Ensure the availability of BPR and filled upto the stage.
- Check the tablet inspection and release status.
Line Clearance Checklist for Packing Line (Tablet & Capsule)
- Check and ensure that the area/ equipment/ belt are visually clean.
- Check the area is free from previous product and unwanted materials
- Check the proper gowning of personnel.
- Check the present status label which shows the details.
- Verify the issued secondary packaging material with respect to BPR
- Ensure the availability of BPR and filled upto the stage.
- Check the carton, show box and shipper specimen for its Batch No., Mfg date, Exp date, price etc.
- Ensure the check weigher are functioning properly.
- Check the cleaning of cartonator M/C and free from the previous product.
- Ensure the REJECTED LABELED container is available for rejected strip/ blister
- Ensure the filling quantity of carton/ shipper.
Line Clearance Checklist for Liquid Manufacturing
- Check and ensure that the area/ equipment/ tank is visually clean.
- Check the area is free from previous product and unwanted materials
- Ensure the temperature and relative humidity are within the specified limit as per mentioned in BMR.
- Check the present status label which shows the details.
- Check the proper gowning of personnel.
- Ensure the availability of BMR and filled upto the stage.
- Ensure that the balance is calibrated and verify the weight of dispensed materials.
- Ensure the filter press is cleaned.
- Check the wash water report of the tank.
Line Clearance Checklist for Filling of Liquid
- Check and ensure that the area/ equipment/ are visually clean.
- Check the area is free from previous product and unwanted materials
- Ensure the temperature and relative humidity are within the specified limit as per mentioned in BMR.
- Check the present status label which shows the details.
- Check the proper gowning of personnel.
- Ensure the availability of BPR and filled upto the stage
- Check the wash water report of tank/ nozzles.
- Check the filled volume of bottles(total no of nozzles)
- Ensure the dust bin is clean and wrap with new poly bags.
Line Clearance Checklist for Packing Line (Liquid)
- Check and ensure that the area/ equipment/ belt are visually clean.
- Check the area is free from previous product and unwanted materials
- Check the proper gowning of personnel.
- Check the present status label which shows the details.
- Verify the issued secondary packaging material with respect to BPR
- Ensure the availability of BPR and filled upto the stage.
- Check the carton , Lable and shipper specimen for its Batch No., Mfg date, Exp date, price etc.
- Check the cleaning of cartonator Machine.
- Ensure the filling quantity of the bottle.
- Ensure the REJECTED LABELED container is available for rejected bottles.
Get documents for Audit preparation in MS-Word FormatView List
No comments:
Post a Comment
Please don't spam. Comments having links would not be published.