Selecting a Local Warehouse
Although reducing the number of international shipments can clearly diminish the likelihood of many external stumbling blocks, the selection of an appropriate warehouse should be made with care.
Key elements that the clinical practitioner should look for include:
[COLOR=“green”]Location
-is there a local depot servicing the country which will host the study?
-does the warehouse have good access to the offices of key national regulatory agencies?
-is it in a location with good flight availability to other in-country site locations?[/color]
[COLOR=“blue”]Facilities
-does it conform to the needs of the researchers?
-is it GMP-compliant?
-is it secure? controlled?
-does it provide for a variety of potential temperature requirements? controlled ambient
(+15ºC to +25ºC)? refrigerated (+2ºC to +8ºC)? frozen (-20ºC)? deep frozen (-70ºC)?
-does it support GMOs and GMO-derived products, if required?
-does it support controlled drug handling, if required?
-does it ensure confidentiality by offering individualized lockers?
-does it have appropriate back-up systems?
-does it support client audit requirements?[/color]
[COLOR=“purple”]Personnel
-is the facility staffed by professional pharmacists?
-are there documented SOPs in place for handling shipments?
-is there a Quality Assurance/Quality Management system in place?
-does the company support the ongoing training of its field personnel?[/color]
[COLOR=“navy”]Services
-can warehouse personnel enable the local distribution of clinical supplies through qualified local transport providers?
-can warehouse personnel manage drug return and destruction?
-is there a domestic network capable of providing services to all approved clinical trial site locations throughout the country?[/color]
[COLOR=“darkorange”]Information Systems
-is there an effective inventory management control system in place?
-are all materials arriving at/departing the facility fully traceable?
-are authorized pharmaceutical users able to verify and view their inventories and
schedules in real-time?[/color]
If the warehousing organization is able to meet these requirements, the utilization of a local warehouse solution may prove to be a viable strategy for reducing the logistical costs and external risks associated with conducting clinical trials in challenging emerging markets.
By some estimates, as many as 40% of all clinical trials will be conducted in emerging nations in Asia, Latin America and Africa by the year 2012. As a word of caution, it is critical that sponsors and other pharmaceutical partners fully understand the local capabilities of their logistics providers in each individual country or market where a study is to be undertaken and not simply draw conclusions based on past experience with a supplier in another part of the world.
GMO = Genetically Modified Organism (Plant product like Plant vaccines, Plant Nutrient foods, Bacterial vaccine, Recombinant proteins,Polysaccharides,Antigens, Antibodies,Chinese Hamster Ovary (CHO) cell line derived producs, Stem cells etc)