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European Biopharmaceutical Review

Classified Information: Shipping Biological Substances

The regulations surrounding the shipment of biopharmaceutical substances can be difficult to judge correctly. Michael Gotz at QuickSTAT offers some helpful pointers

It is self-evident in the biopharmaceutical industry that science is intermeshed with business and regulatory concerns. This principle is readily apparent when it is necessary to ‘classify’ biological substances for shipping purposes. The shipper of a life sciences substance must comply with national and international transportation regulations to determine whether or not it is ‘classified’ as an infectious substance and thus considered dangerous goods. This scientific/medical decision impacts the manner in which the commodity is prepared for shipment as well as the type and availability of transport.

This is particularly significant if, for instance, a clinical trial is conducted in a region where dangerous goods airlift is severely limited – either by regulation or by the airlines themselves. In such cases it can be difficult to get patient samples from the investigator site to the laboratory in the timely manner required for temperaturesensitive shipments. The following discussion is intended as a guide to applying regulatory criteria to the classification of biological substances so as to comply with the law and ensure the timely, successful delivery of critical shipments.

THE REGULATORY ENVIRONMENT

The starting point in the classification process is identifying the regulations. The primary source for international law governing the classification, preparation and transportation of dangerous goods is the United Nations which, through a number of committees, produces a body of law relative to each mode of transport. In turn, national governments promulgate regulations which, for the most part, are ‘harmonised’ with the UN laws, meaning they are essentially the same, regardless of their governmental origin.

All regulations thus agree on the following passage taken from the IATA’s Dangerous Goods Regulations (DGR):

“No person may offer or accept dangerous goods for air transport unless these goods are properly classified, documented, certificated, described, packaged, marked, labelled and in the condition for shipment required by these Regulations.”

The regulations are enforced by governmental regulatory authorities, such as the Federal Aviation Administration (FAA), Civil Aviation Authority (CAA) and similar agencies in most countries. Infringement of the regulations carries stiff penalties, including large monetary fines for civil infractions and jail time for intentional/criminal violations.

The first step is to define ‘dangerous goods’ as applied to biopharmaceutical shipments such as patient samples. Since we are only concerned with whether or not a particular commodity is considered infectious and, hence, dangerous goods, the following definition applies:

Infectious substances are substances which are known or reasonably expected to contain pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents, such as prions, which can cause disease in humans or animals.

It is the shipper’s responsibility to apply regulatory criteria to determine whether a particular shipment meets this definition.


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Michael Gotz is the Director of Dangerous Goods for Quick International Courier and QuickSTAT, the biopharmaceutical shipping specialists. He is responsible for employee, service partner and customer training, as well as regulatory compliance. He holds a PhD from the University of California, Berkeley. Starting at Flying Tigers Airline, he has been working in the dangerous goods/life sciences transportation industry for 22 years.
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