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Transport validation

#1
Any body know about transport validation? I was requested from my supervisor to conduct transport validation for our company. As we need validation of transportation with different climatic condition during product transit, what parameters monitoring required?. Which condition (distance or climax temperature in the country?) we should take as worst condition, how we have to prove the transport modes through various methods [ by air / sea/ road /by active or passive mode]. If it going with among these three conditions, how we validate? Our product is mainly shipping to Asia, Middle East, Africa and Europe country. How to we monitor, pls guide me. We have to initiate transport validation for our product shipping process. Any reference or softcopy that i might refer for protocol?
Thanks and regards
 
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v9991

Trusted Information Resource
#3
https://www.google.com/url?sa=t&sou...ChAWegQIChAB&usg=AOvVaw2RCaiJPJeABkksxQCxKG_l

PDA Technical Report No. 39 (revised 2007). Guidance for Temperature-Controlled
Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal
Products Through the Transportation Environment. Parenteral Drug Association,
2007.
Product Detail
 International Safe Transport Association (ISTA) Series 5B, 7E and Manual 20,
Design and Qualification of Insulated Shipping Containers.
http://www.ista.org/pages/procedures/ista-protocols.php

 WHO PQS catalogue
http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/cate
gorylist.aspx

 WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for the
storage and transport of time- and temperature-sensitive pharmaceutical
Essential Medicines and Health Products Information Portal
 

Candi1024

Quite Involved in Discussions
#4
I would just call a testing company. You will most likely need them to carry out the tests, and they can summarize ISTA , or ASTMD4169-16 for what you need.
 

v9991

Trusted Information Resource
#6
Any body know about transport validation? I was requested from my supervisor to conduct transport validation for our company. As we need validation of transportation with different climatic condition during product transit, what parameters monitoring required?. Which condition (distance or climax temperature in the country?) we should take as worst condition, how we have to prove the transport modes through various methods [ by air / sea/ road /by active or passive mode]. If it going with among these three conditions, how we validate? Our product is mainly shipping to Asia, Middle East, Africa and Europe country. How to we monitor, pls guide me. We have to initiate transport validation for our product shipping process. Any reference or softcopy that i might refer for protocol?
Thanks and regards
the depth of study depends on the product category.,criticality of impact oftransportation phase
viz.,
if it were for low-risk / less-regulated ,then it could be done simulated conditions using the primary pack materials; and other extreme to be done on specific to the product. Similarly is the extent and depth of testing,batch size,noof samples and documentation.
various standards relevant and pertinent for the the product.
Medical Device Transport Validation I3CGLOBAL

Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069) - Canada.ca

https://www.who.int/biologicals/exp...nt-14-TS-route-profiling-final-ECSPP-ECBS.pdf
 
#7
thanks for the reference, now i wondering my worst case situation should based on the distance or the climax temperature? Or should i do both criteria? Is there any justification for the country i choose to conduct my transport validation?
 

v9991

Trusted Information Resource
#8
thanks for the reference, now i wondering my worst case situation should based on the distance or the climax temperature? Or should i do both criteria? Is there any justification for the country i choose to conduct my transport validation?
it must be both, distance ( time) - mode of transportation - and of course temperature ( ref. to product storage conditions )
cited ASTM standard provides the specific & technical details of simulations required for the study; + above regulatory requirements / guidances provide the overall intent and expectations. .( surely, country specific requirements to be considered for smooth review & approval process)
 
#9
Is it a must also to validate the transportation by route to customer once our product have reached the port/airport? In that case we have to do temperature mapping for the vehicle used by road?
 

v9991

Trusted Information Resource
#10
Is it a must also to validate the transportation by route to customer once our product have reached the port/airport? In that case we have to do temperature mapping for the vehicle used by road?
YES.
irrespective of the responsibilities, transportation includes all the steps involved the steps from your dispatch to their inward(warehouse).;
for any reason there is bifurcation of the responsibilities, there needs to be linkage/scoping in the transportaiton documents.!
 
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