SOP for Transport Validation

OBJECTIVE

• Establish the procedure for conducting transport validation and define the acceptance criteria for the study.
• Outline the procedure for a transit study to ensure that high product quality is maintained throughout the distribution network.
• Provide detailed steps for conducting transport validation, including evaluating product integrity and the impact of environmental conditions, such as temperature and relative humidity, on the quality of the finished pharmaceutical product during transport.

SCOPE

This applies to Finished Pharmaceutical Products manufactured at the drug production facility and those produced and dispatched to various locations.

RESPONSIBILITY

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 the consignment.
• To activate the data loggers.
• Ensure the pre-shipment visual inspection of containers.
• To download data from the data loggers after receipt

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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.

CONSIDERATION

• Review the transport route for suitability by assessing the impact of environmental conditions (temperature and relative humidity) on product integrity during transport.
• Ensure that products can be safely transported within the defined temperature profile for each product and demonstrate compliance to regulatory authorities and other interested customers.

DEFINITIONS

Temperature excursion: A temperature excursion is a variance outside of the labeled storage conditions.

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 the customer.
• Whenever temperature and/or humidity monitoring shows unexplained variability 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 transportation study validation team will include personnel from QA, the engineering warehouse, and marketing as needed. QA is responsible for ensuring that all individuals conducting the transport validation are trained in the relevant operations and procedures (SOPs). Additionally, QA must ensure that the data logger is calibrated according to the SOP.
• The warehouse personnel must notify QA at least one day before dispatch, providing details such as the introduction of a new transporter, the transporter’s name, vehicle number, vehicle size, product name, batch number, and the number of packed shippers.
• QA will verify the product and transport details to determine if transport validation is required. If a temperature validation study is needed for the transport vehicle, QA will inform all relevant personnel from the site and the depot/marketing department.
• A data logger will be used according to customer requirements, and QA will provide the transport validation study protocol number.
• The transport validation study number shall be provided as AA/YYNNN

1. AA stands for Transport Validation.
2. YY stands for the last two digits of the current year.
3. NNN is a sequential number starting from 001, 002, and so on.

For Example- AA/24001 indicates that the first Transport validation was performed in the year 2024.

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• QA shall issue the controlled copy of the transport validation protocol to the warehouse.
• The warehouse person shall arrange the shippers/pallets/drums of the product under transport validation.
• The warehouse person shall perform a visual inspection of all the containers to be shipped for cleanness and any defects and record the observations.
• If the transport container is dirty and/or damaged, then wait until 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 comply 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 a case without Palletization and four data loggers in a case 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 have 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-minute frequency interval to take the reading in the data logger.
• Data loggers shall be placed while loading of shippers and the same shall be recorded in a table.
• In case without pallet, the warehouse person shall place the data logger in the Identified shipper/drum (upper corner of shipper drum) of the consignment in the presence of QA.
• When a shipper without a pallet is dispatched and Palletization to be done outside of the manufacturing site then a communication shall be sent to the depot/marketing department as ‘only one shipper labeled as ‘CONTAINS DATA LOGGER’ shall be placed on one pallet.
• In the case of pallets, the warehouse person shall place the data logger on the upper corner of half of the total pallets and on the lower corner of half of the pallets of the consignments in the presence of QA.
• The warehouse person shall label the outer surface on each side of the 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 the data logger in the shipper/pallet/drum.
• QA shall ensure that the temperature and relative humidity of the container are kept at the lower side of the required range and must not cross the specified range during loading the shipper of pallets into containers.
• A real-time photograph of the loading pattern shall be attached with a validation report by QA.
• Diagrammatic representation of the position of the data logger in the vehicle and data logger number to be recorded in a table without pallets.

• The rationale for selection of diagonal location to place data loggers in containers when shippers are without pallet is as below :

S. No.	Grid No.	Data Logger Location	The rationale of the selection of location
1	I	Right side – Upper level	Behind the A.C. unit, Difficult to achieve the desired temperature
2	I	Centre – Middle Level	The location is surrounded by shippers in all directions so the desired temperature is difficult to achieve.
3	I	Left side – Lower Level	To demonstrate temperature distribution in the lower horizontal plane
4	II	Left side – Upper Level	To demonstrate temperature distribution in the upper horizontal plane
5	II	Centre – Middle Level	The location is surrounded by shippers in all directions so the desired temperature is difficult to achieve.
6	II	Right side – Lower Level	To demonstrate temperature distribution in the lower horizontal plane
7	III	Right side – Upper level	To demonstrate temperature distribution in the upper horizontal plane
8	III	Centre – Middle level	The location is surrounded by shippers in all directions so the desired temperature is difficult to achieve.
9	III	Left side – Lower level	To demonstrate temperature distribution in the lower horizontal plane and at the location farthest away from the A.C. unit

• In the case of shippers with pallets, one data logger on each pallet will be located diagonally to demonstrate that temperature is uniformly distributed throughout the vehicle.
• QA shall inform the Export department/marketing department/customer to return the data logger immediately on receipt of the consignment at their end to the plant by courier.
• An 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 a 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 the customer destination (depot), a customer representative shall Check/confirm the physical conditions of the shipment and fill in the details in the data logger tracking sheet.
• Verification of physical condition and product integrity includes (but is not limited to)

1. Wet products
2. Damaged products
3. Tempered products

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• (If required) withdraws samples from the shipper/pallet/drum in which the data logger is placed (quantity required for two-time analysis).
• Upon receipt of the data logger to plant along with tracking sheet and COA of analyzed sample (if samples withdrawn by customer representative), the 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 the 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, a summary of transport validation shall be approved and shared to the customer/marketing person.
• In case, the data logger is provided by the customer then the temperature and relative humidity data shall be provided by the customer to the plant.
• Any deviation such as temperature excursion or product damage that has occurred during transportation, product failure 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.
• A risk assessment shall be performed to consider the impact of variables in the transportation process other than those conditions which are continuously controlled or monitored, e.g. delays during transportation, failure of monitoring devices and any other relevant factors. This risk assessment shall be attached to the validation report.
• In case of data, loggers lost or data loggers get STOPPED in between transport, then the transport validation study shall be considered as invalidated and required to be repeated.

ACCEPTANCE CRITERIA

• There must not be any damage to the product during transport.
• The analytical results of the product must comply with the release specification (if applicable).
• The temperature and relative humidity data must be within the specified range.

ABBREVIATIONS

SOP – Standard Operating Procedure

QC-Quality Control.

QA - Quality Assurance

ANNEXURES

Nil

REVISION HISTORY

Nil

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