Abstract: The pharmaceutical industry is one of the most regulated industries today. The globalization effects resulted in a need for even more strict regulations for the production and distribution practices thus aiming to harmonize the standards for good manufacturing, storage and distribution practices. A number of interest groups and organizations led by the International Air Transport Association and International Civil Aviation Organization, regulated and recommended standards for the transportation of pharmaceutical products where, being a part of the pharmaceutical industry product line, biological substances represent one of the most demanding products for overall production and distribution processes definition. The paper takes into the consideration the regulatory environment against the overall transportation process structure contemplating on a number of process definition recommendations. |