The objective of this study is to establish a procedure to record temperature data to ensure that transportation conditions have not adversely affected a product until it reaches the Central Warehouse when transported as per regular Shipment practice.
The protocol shall be applicable at the formulation Plant. The Shipping (Transportation) validation study shall be carried out four times covering four seasons viz., Winter, Spring, Summer, and Monsoon to know the transit conditions during transportation from Warehouse, Manufacturing to Central Warehouse.
Quality Assurance: Preparation, check, and approval of validation protocol; conducting the experiment as per the approved protocol and compilation of data; preparation, check and approval of validation report and check the data loggers arrangement and product and transport details during setting in the corrugated box and vehicle.
Warehouse: To check and approve the protocol and report with respect to its intended purpose; arrangement and setting of Data Loggers as per specified locations, compile the product and transport details and support the validation activity as per the predetermined protocol.
Central Warehouse: Sent the Data-loggers after completion of transit to Quality Assurance, for further evaluation of data.
Validation Team members
Validation team shall comprise the representatives from following functions:
USP: United States Pharmacopoeia
Pre-requisites for Validation
Product: Three different batch numbers of one strength and/or three different strengths of any product
The following external instruments are to be used for Mapping the Environmental Conditions (Temperature) in the Transport Vehicle.
Means of Transportation ( Truck)
Relevant Geographical and Transportation Route Maps
The Temperature shall not be varying from the specified storage conditions.
Ensure proper working and initial adjustments of the calibrated data loggers before using them for the study.
Ensure the Means of Transportation for proper storage environment for Temperature.
Before Dispatch of Finished goods Place four Data Loggers as per the pre-decided location.
Place three data loggers (D1, D2, and D3) into loose packs of three different batch numbers of one strength and/or three different strengths of any three different product corrugated boxes.
Label the corrugated boxes with the details like shipping validation, product name, batch no., strengths, and data logger arranged by and checked by.
Place one data logger (D4) inside of the truck but not in the shipper.
Place the data logger in a suitable location within the transportation vehicle.
Arrange the three corrugated boxes having data loggers as per the given locations.
Record the details.
After reaching the destination, during unloading isolate the data loggers D1, D2, D3, and D4 and send them back to Quality Assurance Department.
After receiving the data loggers take the printout and review the temperature data for the above four data loggers (D1, D2, D3, and D4) for evaluation of transportation conditions.
Repeat the exercise quarterly on per seasonal basis in four phases, once in the preferred months of
- November, December & January (Winter Season)
- February, March & April (Spring Season)
- May, June & July (Summer Season)
- August, September & October (Monsoon Season)
Summarize the results season-wise and record the excursions (if any) in temperature.
An intermittent report shall be prepared on the basis of phase wise results.
After completion of one year, final report shall be prepared on the basis of results obtained.
In the view of the following list, the test shall be re-conducted if there is:
Any major change in the Manufacturing process.
Any major change in Transportation mode / route.
Any major change in Storage conditions.
Deviations and Investigations
Any deviation to this protocol and thereupon investigation shall be recorded.
Based on the outcome from this validation study, a report shall be prepared by Quality Assurance. The validation report shall be checked and then approved by all functional heads of all the concerned departments. Validation Report shall include the following:
Cover page of the Report
Validation Report Approval Sheet
Details of Shipping Validation Study
Other Supporting Documents (Transportation Agreement and Relevant Geographical Maps)
Validation Report Summary & Conclusion
List of Annexures / Formats attached
|Arrangement of Data Loggers
|Details of Shipping Validation Study
|Cover page of the Report
|Validation Report Approval Sheet
|Validation Report Summary & Conclusion
- In–House Method.
- Good Storage and Shipping Practices <1079>: USP 43.