Shipping validation
Objective
The objective of this study is to establish a procedure to records temperature data to ensure that transportation conditions have not adversely affected a products, when transported as per regular Shipment practice.
Scope
The Shipping (Transportation) validation study shall be carried out for four times covering four seasons viz., Winter, Spring, Summer and Monsoon to know the transit conditions during transportation.
Responsibility
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.
Destination Warehouse: Sent the Dataloggers after completion of transit to Quality Assurance, for further evaluation of data.
Validation team shall comprise of the representatives from following functions:
Validation Team members
USP : United States Pharmacopoeia
Abbreviations
Quality Assurance
Pre-requisites for Validation
Product: Three different batch numbers of one strength and / or three different strengths of any product
Equipments/Instruments
The following external instruments are to be used for Mapping of the Environmental Conditions (Temperature) in Transport Vehicle.
| S. No. | Instrument Name | Make | Range |
Any deviation to this protocol and thereupon investigation shall be recorded.
Deviations and Investigations
Any major change in Storage conditions.
Any major change in Transportation mode / route.
Any major change in the Manufacturing process.
In the view of following listed, the test shall be re-conducted if there is:
Re-validation
Summarize the results for 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.
Arrange the three corrugated boxes having data loggers.
Record the details.
After reaching the destination, during unloading isolate the data loggers D1, D2, D3 and D4 and send 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 as 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)
The Temperature shall not be varying from the specified storage conditions.
Acceptance Criteria
Relevant Geographical and Transportation Route Maps
Transportation Agreement
Documents
Means of Transportation (Truck)
Procedure
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 given Layout.
Place three data loggers (D1, D2 and D3) into loose packs of three different batch numbers of one strength and / or three different strengths any three different product corrugated boxes.
Label the corrugated boxes with the details like shipping validation, product name, batch no., strengths, 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.
Validation Report
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 following:
Cover page of the Report
Validation Report Approval Sheet
Details of Shipping Validation Study
Temperature
Other Supporting Documents (Transportation Agreement and Relevant Geographical Maps)
Validation Report Summary & Conclusion
SUMMARY AND CONCLUSION:
Note: The duration may be changed put as per the executed duration.
- Data of four seasons:
- Area:……………………………………….
- Location of data logger:…………………..
- Data logger ID:…………………………….
Spring Season (recommended months Feb, Mar, April) :
| — | Day | Day-1 | Day-2 | Day-3 | Day-4 | Day-5 | Day-6 | Day-7 | Parameter | Values |
| Temp. (°C) | Max* | Max. value among 7 days | ||||||||
| Min* | Min. value among 7 days | |||||||||
| % RH | Max* | Max. value among 7 days | ||||||||
| Min* | Min. value among 7 days |
Summer Season (recommended months May, Jun, Jul):
| — | Day | Day-1 | Day-2 | Day-3 | Day-4 | Day-5 | Day-6 | Day-7 | Parameter | Values |
| Temp. (°C) | Max* | Max. value among 7 days | ||||||||
| Min* | Min. value among 7 days | |||||||||
| % RH | Max* | Max. value among 7 days | ||||||||
| Min* | Min. value among 7 days |
Monsoon Season (recommended months Aug, Sep, Oct):
| — | Day | Day-1 | Day-2 | Day-3 | Day-4 | Day-5 | Day-6 | Day-7 | Parameter | Values |
| Temp. (°C) | Max* | Max. value among 7 days | ||||||||
| Min* | Min. value among 7 days | |||||||||
| % RH | Max* | Max. value among 7 days | ||||||||
| Min* | Min. value among 7 days |
Winter Season (recommended months Nov, Dec, Jan):
| — | Day | Day-1 | Day-2 | Day-3 | Day-4 | Day-5 | Day-6 | Day-7 | Parameter | Values |
| Temp. (°C) | Max* | Max. value among 7 days | ||||||||
| Min* | Min. value among 7 days | |||||||||
| % RH | Max* | Max. value among 7 days | ||||||||
| Min* | Min. value among 7 days |
Data shall be over the period of 24 hrs.
Four Seasons:
| — | — | Parameter | Value |
| Temperature (°C) | Max | Max. value among four seasons | |
| Min | Min. value among four seasons | ||
| % RH | Max | Max. value among four seasons | |
| Min | Min. value among four seasons |
Data of all Hygrometers:
| — | Day | D-1 | D-2 | D-3 | D-4 | D-5 | D-6 |
| Temp. (°C) | Max | ||||||
| Min | |||||||
| % RH | Max | ||||||
| Min |
Conclusion