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Pharmaceutical Carriage Qualification


Regulatory authorities such as the UK (MHRA), European (EMEA) and US (FDA) regulatory authorities require the qualification of temperature controlled transport equipment GDP (good distribution practice).

The Official Journal of the European Union has issued Guidelines (7th March 2013) on:
Good Distribution Practice of Medicinal Products for Human Use.

Pharmaceutical products require to be conditioned and maintained at temperatures to ensure that they lose none of their potency and efficacy.

Some products, for example-fractionised plasma, are stored frozen and rules sets out in such publications as the European Pharmacopoeia have strict requirements for temperature deviation.

Transportation can be by multiple techniques utilising active and passive temperature control systems.

Such systems include:

Insulated mini containers 
Air freight pallet shippers
Insulated containers with eutectics/dry ice
Insulated air freight containers with eutectics
Insulated refrigerated containers
Insulated refrigerated air freight
Refrigerated vehicles

In addition, pharmaceutical equipment must follow validation protocols that provide evidence that the equipment is fit for its intended purpose. These provide a high degree of assurance that the carriage criteria will consistently meet requirements.

Within our environmental chambers we can temperature map and thermally validate the equipment within a temperature range between -20 and +50C.


related information

ISO International Standards Organization

BS EN standards

american ANSI standards

ebook: "A Global Review of Good Distribution Practices"

paper on pharmaceutical validation

Environmental management of refrigeration equipment

Maintenance of refrigeration equipment

Qualification of temperature controlled road vehicles

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