Transport Validation

GOOD VALIDATION PRACTICE (cGVP)
1

Hi,

Forum Experts,

I wanted to know that the is the Transport Validation is required for products which are transferring at ambient condition or products shelf Life assigned based on Real time data Stability study which was conducted at 25±2C. These products are transferring at normal conditions by air and there as no specific storage conditions are being maintained.
How much excursions it can be acceptable?
Can we consider the mean temperature if temperature recorded 60 deg.C during the transit.

Kindly give me your valuable feed back so that it can be helpful to us.

2

Not an expert, but you have to answer the question for yourself. In other words, you need to determine, via testing, what excursions are possible without changes to the quality of the product. If transportation raises the temperature enough to change the quality and efficacy, you need to find another way to ship. Insulated container? climate controlled carrier. etc.