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Template Protocol for 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

 

  • Distribution
  • Quality Assurance, Production, Quality Control,warehouse.
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP

 

 

  • 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:

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