1.0 OBJECTIVE
2.2 The product should pass the tests listed below as per limits specified, after shipment from [Origin] to [Place 2] and back to [Origin].
Test to be carried out and their limits are as below.
3.0 RESPONSIBILITIES
4.1 Methodology
4.1.1 Fill two batches of (Product Name) in Aluminium containers supplied by [Supplier Name] having 5 Kg sterile material to fill in each container.
4.1.2 Sample the material as per sampling SOP for sampling before transportation and for control purpose.
4.1.3 Transfer the container to the packing room.
4.1.4 Label the container.
4.1.5 Keep the container in Thermocol box.
4.1.6 Put the container in shipper box.
4.1.7 Paste label on shipper box.
4.1.8 After approval of QC, load 2 shipper boxes of each batch on the vehicle.
4.1.9 Send the material to [Place 1] by road in a lorry, normally utilized for transportation of the material.
4.1.10 [Place 1] depot will further send the boxes to [Place 2] and [Place 2] depot will send the container back to [Origin].
4.1.11 On receipt of shipper boxes at [Origin], inspect shipper boxes for any visible damage from outside.
4.1.12 Transfer the boxes to the decartoning room of vial filling plant.
4.1.13 Observe the containers for any physical damage.
4.1.14 Record the observations.
4.1.15 If no damage is observed to the containers, transfer the containers to the sterile area of vial filling plant for sampling by Microbiologist.
4.1.16 Withdraw about 30 g sample from each container for post transportation analysis.
4.1.17 Tabulate the data generated. Compare the data obtained before the transportation and after receiving the material back at [Origin].
4.2 Worst Case Situation
4.2.1 The lorry without any temperature control system will be used, hence the material will experience temperature between 22 to 35°C during transit.
4.2.2 In routine case the material for export is transported from [Origin] to [Place 1] by road and thereafter it is transported by Air. However, for this study, the material will be brought back to [Origin] via [Place 1] thus traveling more than double the distance by road. This situation provides the worst case for the physical properties of the material.
4.3 Microbiological Method
4.3.1 Soybean Casein Digest Medium will be prepared as per the SOP in the plant autoclave and sterilize for 30 minutes at 121° C.
4.3.2 After sterilization of the media the container will be sealed with aluminum seal.
4.3.3 After sterilization it will be transferred to the parking area.
4.3.4 Label the container.
4.3.5 The container having media will be packed with a polyethylene bag and then placed within the shipper box.
4.3.6 Keep the container in Thermocol box.
4.3.7 Put the container in shipper box.
4.3.8 Paste label on shipper box.
4.3.9 Send the material to [Place1] by road in a lorry, normally utilized for transportation of the material from [Origin] to [Place 1] during export.
4.3.10 [Place 1] depot will further send the boxes to [Place 2] and [Place 2] depot will send the container back to [Origin].
4.3.11 On receipt of shipper boxes at [Origin], inspect shipper boxes for any visible damage from outside.
4.3.12 Bring the shipper box in the microbiology lab.
4.3.13 Place the container in the LAF in the controlled area.
4.3.14 Tilt the container slowly and sample 100 ml of the medium and check for the sterility of the medium.
4.3.15 Sample 100 ml of the medium for Growth Promotion Test if no growth is observed in the media
4.4 Worst Case Situation
1.1 To evaluate the effect of transportation on the quality of (Product Name) packed in standard primary and other packaging systems.
1.2 To evaluate the effect of transportation by air on the sterility of material filled into Aluminum containers supplied by M/S [Supplier Name].
2.0 ACCEPTANCE CRITERIA
2.1 The physical status [shape and integrity] of the primary and another packaging should not have any damage, on transportation. 2.2 The product should pass the tests listed below as per limits specified, after shipment from [Origin] to [Place 2] and back to [Origin].
Test to be carried out and their limits are as below.
Tests
|
Limits
|
Description
|
|
Assay
|
|
Clarity of
Solution
|
|
Loss on Drying
|
|
Related
Substances
|
|
Total
Impurities
|
|
pH
|
|
Sterility
|
|
Particle Size
|
|
Bulk Density
|
3.0 RESPONSIBILITIES
Validation group
consists of the following members:
3.1 *****
3.2 *****
3.3 *****
4.0 VALIDATION TEST PROCEDURE3.1 *****
3.2 *****
3.3 *****
4.1 Methodology
4.1.1 Fill two batches of (Product Name) in Aluminium containers supplied by [Supplier Name] having 5 Kg sterile material to fill in each container.
4.1.2 Sample the material as per sampling SOP for sampling before transportation and for control purpose.
4.1.3 Transfer the container to the packing room.
4.1.4 Label the container.
4.1.5 Keep the container in Thermocol box.
4.1.6 Put the container in shipper box.
4.1.7 Paste label on shipper box.
4.1.8 After approval of QC, load 2 shipper boxes of each batch on the vehicle.
4.1.9 Send the material to [Place 1] by road in a lorry, normally utilized for transportation of the material.
4.1.10 [Place 1] depot will further send the boxes to [Place 2] and [Place 2] depot will send the container back to [Origin].
4.1.11 On receipt of shipper boxes at [Origin], inspect shipper boxes for any visible damage from outside.
4.1.12 Transfer the boxes to the decartoning room of vial filling plant.
4.1.13 Observe the containers for any physical damage.
4.1.14 Record the observations.
4.1.15 If no damage is observed to the containers, transfer the containers to the sterile area of vial filling plant for sampling by Microbiologist.
4.1.16 Withdraw about 30 g sample from each container for post transportation analysis.
4.1.17 Tabulate the data generated. Compare the data obtained before the transportation and after receiving the material back at [Origin].
4.2 Worst Case Situation
4.2.1 The lorry without any temperature control system will be used, hence the material will experience temperature between 22 to 35°C during transit.
4.2.2 In routine case the material for export is transported from [Origin] to [Place 1] by road and thereafter it is transported by Air. However, for this study, the material will be brought back to [Origin] via [Place 1] thus traveling more than double the distance by road. This situation provides the worst case for the physical properties of the material.
4.3 Microbiological Method
4.3.1 Soybean Casein Digest Medium will be prepared as per the SOP in the plant autoclave and sterilize for 30 minutes at 121° C.
4.3.2 After sterilization of the media the container will be sealed with aluminum seal.
4.3.3 After sterilization it will be transferred to the parking area.
4.3.4 Label the container.
4.3.5 The container having media will be packed with a polyethylene bag and then placed within the shipper box.
4.3.6 Keep the container in Thermocol box.
4.3.7 Put the container in shipper box.
4.3.8 Paste label on shipper box.
4.3.9 Send the material to [Place1] by road in a lorry, normally utilized for transportation of the material from [Origin] to [Place 1] during export.
4.3.10 [Place 1] depot will further send the boxes to [Place 2] and [Place 2] depot will send the container back to [Origin].
4.3.11 On receipt of shipper boxes at [Origin], inspect shipper boxes for any visible damage from outside.
4.3.12 Bring the shipper box in the microbiology lab.
4.3.13 Place the container in the LAF in the controlled area.
4.3.14 Tilt the container slowly and sample 100 ml of the medium and check for the sterility of the medium.
4.3.15 Sample 100 ml of the medium for Growth Promotion Test if no growth is observed in the media
4.4 Worst Case Situation
4.4.1 Normally the product is filled aseptically into the containers and the containers are sealed and packed and are transported to the destination. In the present study, the containers containing sterile media were used, which had already traveled from [Origin] to [Place 2] and back to [Origin] by road, after their receipt from road transportation, the containers were desealed for sampling.
5.0 EVALUATION OF RESULTS
5.1 Evaluations should be based on the basis of :
The comparison of the physical status of shipper box, label, seal and container before and after transportation itself will establish that packaging is satisfactory and no damage has occurred during transit.
5.2 The comparison of the analytical and microbiological data will establish the effect of transportation on the quality of the product.
5.3 On the basis of the results of the test for sterility, and physical observations it is concluded that the containers are suitable for transportation by air and the integrity of the containers (seal) is not affected at high altitudes, which may cause pressure differentials during transportation by air.
7.0 DOCUMENTATION:
Validation Report contains the following documents.
A summary report will contain discussion and conclusion, which clearly state the successful achievement of the objective of transport validation studies.
5.0 EVALUATION OF RESULTS
5.1 Evaluations should be based on the basis of :
The comparison of the physical status of shipper box, label, seal and container before and after transportation itself will establish that packaging is satisfactory and no damage has occurred during transit.
5.2 The comparison of the analytical and microbiological data will establish the effect of transportation on the quality of the product.
5.3 On the basis of the results of the test for sterility, and physical observations it is concluded that the containers are suitable for transportation by air and the integrity of the containers (seal) is not affected at high altitudes, which may cause pressure differentials during transportation by air.
6.0 SCHEDULE REVALIDATION
Revalidation shall be carried out in case of a new vendor for the container is approved.7.0 DOCUMENTATION:
Validation Report contains the following documents.
- Approved Validation protocol
- Test reports
- Summary Conclusion
A summary report will contain discussion and conclusion, which clearly state the successful achievement of the objective of transport validation studies.
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