Distribution or Transport Validation SOP
Objective / Purpose
- To lay down the procedure for conducting transport validation and to describe acceptance criteria for the study.
- To lay down a procedure for transit study to ensure that the high level of product quality is maintained throughout the distribution network.
Scope
- Applicable for Finished Pharmaceutical Products manufactured at the drug manufacturing location and products manufactured and dispatched to various locations.
Responsibility
Validation and Quality Assurance:
- To prepare and review the protocol for transport validation.
- Issue the protocol.
- Ensure data loggers are calibrated.
- To compile and review the data of transport validation.
Engineering:
- To facilitate the calibration of the data logger.
Warehouse:
- Placement of data loggers in the consignment.
- Perform a pre-shipment visual inspection of consignment.
- To activate the data loggers.
- Ensure the pre-shipment visual inspection of containers.
- To download data from the data loggers after receipt.
Quality Assurance Manager:
- To approve the transport validation protocol and report.
Customer:
- To check the physical condition of the consignment.
- Record the details in the data logger tracking sheet.
- To send the data logger or temperature and relative humidity data to the plant.
Revalidation Criteria
The transport revalidation shall be done in case of:
- Change in route of transportation.
- For new transporter.
- Change in the port of destination.
- Any recommendation by customer.
- Whenever temperature and/or humidity monitoring shows unexplained variability that is greater than normal.
- The extent of transport revalidation shall depend on the significance and nature of changes, which shall be evaluated by QA.
Procedure
- The validation team for the transportation study shall consist of personnel from QA, Engineering warehouse, and marketing (wherever required).
- QA shall ensure that persons carrying out the transport validation must be trained on respective operations/procedures (SOPs).
- QA shall ensure that the data logger is calibrated as per SOP.
- Warehouse person shall inform QA about the details such as the introduction of new transporter, name of the transporter, vehicle number, and vehicle size, product details such as the name of the product, batch number, and the number of packed shippers at least for one day in advance before dispatch.
- QA shall verify the products and transport details and evaluate that transport validation is required or not.
- If temperature validation study is applicable on the transport vehicle, QA shall communicate to all the concerned persons from the site and depot/marketing department regarding the same.
- Data logger shall be used as per customer requirements.
- QA shall provide the transport validation study protocol number.
- Transport validation study number shall be provided.
- QA shall issue the controlled copy of the transport validation protocol to the warehouse.
- Warehouse person shall arrange the shippers/pallets/drums of product which is under transport validation.
- If the transport container is dirty and/or damaged, then wait until unless it is cleaned and/or rectified.
- QA shall ensure the pre-shipment visual inspection of containers along with the warehouse person.
- Quality Assurance shall ensure that packed products are complying with the approved specifications.
- QA shall calculate the dimension of the vehicle (i.e. length and width) which is provided by the warehouse and divide the area into a grid of approximately ’10 feet X 10 feet (i.e. 100 square feet).
- If the area is smaller than 100 square feet, consider it as one grid.
- Arrange a minimum of three data loggers for each grid in case of without Palletization and four data loggers in case of with Palletization.
- QA shall check the battery level of each data logger, preferably the battery level shall be 100% but shall not be less than 90% level (if applicable).
- In case, data loggers are having a battery level near 90% then QA shall provide a spare battery to the transporter and make him understand to change the battery if required.
- The warehouse person shall switch on the data logger and set the program in data loggers to record the temperature and relative humidity.
- The warehouse person shall set a minimum of 15 minutes frequency interval to take the reading in the data logger.
- Data loggers shall be placed while loading of shippers and same shall be recorded in a table.
- In case of without pallet, warehouse person shall place the data logger in Identified shipper / drum (upper corner of shipper drum) of the consignment in presence of QA.
- When shipper without pallet shall be dispatched and Palletization to be done at outside of manufacturing site then a communication shall be send to depot / marketing department as ‘only one shipper labeled as ‘CONTAINS DATA LOGGER’ shall be placed on one pallet.
- In case of with pallet, warehouse person shall place the data logger on upper corner on half of the total pallets and on lower corner on half of the pallets of the consignments in presence of QA.
- Warehouse person shall label the outer surface on each side of shipper / pallet /drum which contains the data logger as ‘CONTAINS DATA LOGGER; as per site SOP for labeling.
- QA shall verify the functioning and placement of data logger in the shipper /pallet / drum.
- QA shall ensure that temperature and relative humidity of container keeps at lower side of required range and must not cross the specified range during loading shipper of pallets in to containers.
- Real time photograph of loading pattern shall be attached with validation report by QA.
- Diagrammatic representation of the position of data logger in the vehicle and data logger number to be recorded in a table for without pallet.
- In the case of shippers with pallets, one data logger on each pallet to be located diagonally so as to demonstrate that temperature is uniformly distributed, throughout the vehicle.
- QA shall intimate the Export department/marketing department/customer to return the data logger immediately on receipt of the consignment at their end to plant by courier.
- Uncontrolled copy of the approved protocol shall be sent to the consignee either with the shipment or through the mail (scanned copy) or both by warehouse person.
- The warehouse person shall seal the container.
- After completion of packing, the shipment shall be sent to the customer’s destination.
- Upon receipt of shipment at customer destination (depot), a customer representative shall Checks / confirms the physical conditions of shipment and fill the details in the data logger tracking sheet.
- Upon receipt of the data logger to plant along with tracking sheet and COA of analyzed sample (if samples withdrawn by customer representative), warehouse person shall stop the data logger if the data logger is software operated and shall collect the data from data loggers.
- QA shall attach these documents (data from data logger, data logger tracking sheet, and COA of the analyzed sample) with the protocol.
- QA shall review the results of analyzed samples and evaluate the compliance.
- The analytical results and data from the data logger shall be compiled in a report and attached to the protocol.
- After review and evaluation of data, summary of transport validation shall be approved and shared to customer / marketing person.
- Any deviation such as temperature excursion or product damage has occurred during transportation, product fails during analysis and departure from protocol instruction shall be recorded and investigated as per SOP for deviation handling.
- Product stability data must demonstrate the acceptable temperature excursion time during transport.
- Risk assessment of delivery routes shall be used to determine where temperature controls are required.
Read also:
Reference (s):
- WHO Technical Report Series 961, 211 –Annex 9
- European Commission Guideline on good Distribution Practice of medicinal products for human use (2013/C 343/01)
