2985 Springboro West
Dayton, OH 45439
Phone: + 1.888.323.9576
International: +1 937 506-4058
Dayton, Ohio, USA, April 4, 2012
The efficient transportation of materials of any kind can be a challenge for even the best-run company, organization, or institution. This challenge increases when those materials are temperature-sensitive, and grows exponentially when the safe arrival of those temperature-sensitive materials will save lives. This is the case with the pharmaceutical industry, where even the smallest fluctuation in temperature over an extended period can have devastating effects on product quality and effectiveness.
Because of these concerns, countries throughout the globe have established organizations to ensure the safe transportation of pharmaceuticals. These organizations have developed strict guidelines that ensure the safe transfer of shipments from their point of manufacture to their point of delivery. A number of the more notable organizations include The United States Food and Drug Administration, Health Canada, the European Commission, and The World Health Organization.
The expansion in the number of regulations, guidelines, and laws regarding the safety, quality, and efficacy of today’s pharmaceuticals has grown rapidly over the past half-century. Many of these additions were introduced in response to a number of pharmaceutical tragedies that had taken place in the 1950’s and 1960’s. These incidents emphasized the need for an international approach towards oversight to match the internationalization that was taking place in global markets (Castner, Hayes, & Shankle, 2007). The following is a brief introduction to a few international organizations working to protect the transfer of pharmaceuticals.
United States Food and Drug Administration
The Food and Drug Administration (FDA) regulates pharmaceuticals in The United States through the oversight of their storage and handling. The FDA’s Code of Federal Regulations, Title 21, Sub-chapter C, Part 205 Sec. 205.50 (c) establishes a set of guidelines for the review of facilities, security, and storage of pharmaceuticals. The FDA also provides guidelines on the examination of materials, approved record keeping, written policies and procedures, and the maintaining of a chain of responsibility (U.S. Food and Drug Administration, 2011).
Although not a part of health regulations, Canada’s Guidelines for Temperature Control of Drug Products During Storage and Transportation (GUI-0069) outlines the compliance requirements for warehousing and storage, product transportation, container specifications and labeling, and the reception of temperature sensitive health products. As to shipping pharmaceuticals, the guidelines specify that it is critical that containers are qualified, have calibrated sensors and alarms, and are protected from adverse weather conditions. What’s more, documentation of the shipping and transportation procedures of pharmaceuticals should be clearly established and communicated to those who have contact with or handle the shipment (Health Products and Food Branch Inspectorate, 2011).
The European Commission
The European Commission’s recently published recommended guidelines on distribution of pharmaceuticals takes a broader approach than other nations. It specifies that a quality pharmaceutical transportation system must be based on a process of review and monitoring, risk management, operations, and documentation. For example, proper pharmaceutical logistics must include the qualification of suppliers and customers as well as the establishment of controls for storage, packing, and delivery. In addition, documentation serves as a way of establishing and communicating standard operating procedures as well as recordkeeping and data collection and storage. Important keys are accuracy, clarity, and detail (European Commission, 2011).
The World Health Organization
A key responsibility of the World Health Organizations’ (WHO) Expert Committee on Specifications for Pharmaceutical Preparations is the development of the norms, standards, and guidelines that assure quality control in the area of pharmaceuticals. The WHO Expert Advisory Panel on The International Pharmacopoeia and Pharmaceutical Preparations’ decisions play an integral role in global initiatives involving both governmental and non-governmental organizations. The Committee meets each year to report all adopted guidelines as part of the WHO Technical Report Series (World Health Organization, 2011).
Meeting the Needs of Pharmaceutical Cold Chain Distribution
To meet the requirements set down by these pharmaceutical watch groups, CSafe pioneered the development of active pallet shippers that leverage the cold chain industry’s leading thermal management technologies. The company’s flagship RKN thermal pallet shipper directly addresses the challenges of providing superior temperature management, by ensuring precise temperature control and detailed data tracking.
Transport with Confidence
CSafe’s RKN active pallet shipper is the first and only compressor-driven refrigeration unit of its kind approved by The European Aviation Safety Administration (EASA) and Federal Aviation Administration (FAA). The RKN is ideal for transporting pharmaceuticals, maintaining the internal temperature of its payload compartment, and functioning even in extreme or fluctuating ambient environments of -30°C to +49°C.
Precise Temperature Control
The RKN utilizes ThermoCor® high-performance insulation along with high-efficiency refrigeration and heating systems for precise control of temperature-sensitive shipments, and its extended battery operation (over 120 hours at +20°C) and precise temperature management (ranges of +4° to +25°C), along with a proprietary air movement and temperature control system, ensure precise temperatures during the transportation of sensitive cargo.
The onboard data tracking device within the RKN provides a sophisticated data logging system with real-time shipment activity. The device records all pertinent information, from door openings to the verification that the cargo has been maintained at the required temperature during all phases of transport.
About CSafe, LLC
To fulfill the requirements of today’s regulating bodies, global pharmaceutical distribution requires not only quality operations, but also tracking of standard operating procedures and detailed data reporting. CSafe, LLC has a full range of proven products, and a worldwide network of logistics partners ready to address the stringent requirements of this temperature sensitive air cargo market. Headquartered near Dayton, Ohio, CSafe, LLC is a joint venture between AmSafe, Inc. and AcuTemp Thermal Systems, with service centers and partners worldwide. For more information, visit www.csafellc.com.
Castner, M., Hayes, J., & Shankle, D. (2007). Social and Environmental Factors: The Growing Emergence of Global Standards. International Trade and Contemporary Trends. Retrieved from http://www.duke.edu/web/soc142/team2/social.html#citations
European Commission: Health and Consumers Director-General. (2011). Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use: Public Health and Risk Assessment Pharmaceuticals.
Health Products and Food Branch Inspectorate. (2011). Guidelines for Temperature Control of Drug Products during Storage and Transportation: GUI-0069.
U.S. Food and Drug Administration. (2011). CFR – Code of Federal Regulations Title 21. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=205.50
World Health Organization. (2011). World Health Organization Expert Committee for Pharmaceutical Preparations: Forty-fifth Report. WHO Technical Report Series. Retrieved from http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf