Distribution of the clinical Trial Materials (CTMs), a single step but with multiple challenges which finally leads to reaching the CTMs to the final destination i.e. to the right patient at the right time! Not meeting any of the challenges i.e. not delivering in time or delivering a damaged product leads to patient not taking the CTM as per the design of the study protocol, finally loosing reputation and prestige of a pharmaceutical or a biotechnology business partner.
One of the biggest challenges in distribution is to store and / or ship the CTM at right temperature. A temperature excursion means that a temperature measuring unit i.e. a data logger/ temp tale measures the temperature of the drug that has been shipped or stored incorrectly or that lacks the proper documentation to show it was shipped correctly and the drug may have to be returned and disposed off. If the drug is stable enough to bear the temperature excursion point then on sponsor’s approval, drug may be allowed to use further for the said study. A reliable and properly documented system gives the concerned pharmaceutical and/ biotech drug manufacturers a confidence in the total cold chain system.
A temperature and environment controlled supply chain which ensures the stability of temperature sensitive CTMs i.e. vaccines/ biologics, throughout the transportation becomes the basis of a cold chain system. The cold chain starts right from facility of manufacturing and packaging of the drug, to wholesaler maintaining throughout the storage conditions comprising of warehouses, from pick up site by transportation using containers/ vehicles, to the delivery destination i.e to the medical facility and finally till the doctor prescribes the drug to patient for consumption.
To protect a product from damage in an especially cold chain shipment, protective packaging is necessary which includes transportation in validated shippers, providing temperature monitors/ data logger in each pack to monitor any temperature excursions/ using qualified carriers. The warehouse personnel, drivers, pilots need to be well trained to handle any situation during storage/ transportation. Once delivered, the records need to be checked thoroughly. Companies can go with an qualified and experienced logistic partner or if to handle on its own they should be updated on current regulations and know the correct packaging solution to be used for their product.
The need of a smooth cold supply chain matters not only for the reputation of the manufacturer or supplier due to product damage, but also is a very harmful risk to the patient in whom the drug may be ineffective or may cause adverse reaction leading to regulatory issue, paying fines and even imprisonment.
An equally important task is providing proper documentation to ensure the product has not been damaged or tampered and meeting all regulations. The various international regulations have their own unique requirement when following temperature-controlled formulations. Distribution regulations for the cold chain cover product manufacturing, packaging, storage, and shipping and handling, and proper documentation. The jurisdiction of the FDA is primarily in the U.S. and Puerto Rico, the ICH is a global organization that involves the U.S., Japan and the European Union.