Protocol for Shipping validation

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

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