A stable and secure temperature-controlled environment is crucial when transporting pharmaceutical products and for ensuring their efficacy. Thermo King, a manufacturer of transport temperature control solutions for a variety of mobile applications and a brand of Ingersoll Rand, addresses the needs and expectations of the pharmaceutical industry with its new comprehensive PharmaSolutions offering.
Pharmaceutical companies rely heavily on controlled and uncompromised transport of pharmaceutical products while they change hands through the distribution network. The revised European Union Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use that comes into effect on 8 September 2013 underlines the importance of quality management throughout the supply chain and assigns roles and responsibilities to all distribution partners involved.
"PharmaSolutions is a platform dedicated to the needs of pharmaceutical manufacturers, distributors and logistics providers. It will aid the implementation of best practices and adoption of quality standards across the transportation network," said Seetha Sasikala, vertical marketing leader for Thermo King and Trane in the Europe, Middle East, India and Africa region.
"PharmaSolutions provides vital application expertise and a customized service portfolio for companies to effectively manage risks, ensure pharmaceutical product integrity, and improve compliance to GDP guidelines during transportation."
With PharmaSolutions, pharmaceutical manufacturers and transporters can benefit from a single point of contact, a trusted expert and a committed partner that will help them meet their distribution and compliance challenges. PharmaSolutions leverages 75 years of Thermo King expertise to deliver application know-how and a broad spectrum of services spanning certification and qualification of transport refrigeration equipment to distribution process verification, fleet management and training.
Systems application expertise delivered through PharmaSolutions covers refrigeration equipment set-up and operating guidelines that are critical-to-know for any pharmaceutical transportation partner. Pharmaceutical transporters can rely on the extensive Thermo King dealer network for guidance on installation and use of refrigeration equipment for road transportation.
Specialist services offered through PharmaSolutions include:
- Certification services cover a range of rigorous functional and performance tests including thermal mapping of trailers and trucks from -32˚C to +60˚C, carried out to validate any refrigerated transport equipment in a controlled environment. These services are provided through the Ingersoll Rand Engineering and Technology Center (IRETC) in Prague, Czech Republic. This research and development lab is ISO 9001: 2000, ISO 14001 and ISO 18000 accredited and authorized for ATP certification.
- Qualification services provide documented evidence to demonstrate that the refrigerated vehicle is able to maintain internal temperatures within specified regimes during standard operating modes. The validation tests conducted are documented and approved by "Qualified Persons" (QP).
- 24/7 fleet monitoring services will allow end-to-end management of a refrigerated fleet to improve efficiency of the pharmaceutical distribution network and enable proactive measurement of critical parameters and timely management of operations.
- Training services delivered by PharmaSolutions experts will help enable compliance within the distribution chain. The training for drivers, fleet operators and distribution managers aids in understanding GDP guidelines and other areas that pose high risks to product quality.
- Advisory services from PharmaSolutions provide factual and standards-based guidance that includes audits to map and qualify delivery temperatures. In addition, it helps define standard operating procedures (SOPs) to improve pharmaceutical quality management processes.
Pharmaceutical manufacturers and transporters can benefit from this broad spectrum of services individually or can combine select services into a PharmaKare service contract customized to their needs.
Through PharmaSolutions, Thermo King offers pharmaceutical companies and their distribution partners comprehensive support to reduce operational risks and meet regulatory expectations with the ultimate aim of preserving product quality and integrity.
 Source: http://ec.europa.eu/health/human-use/index_en.htm
 Agreement on the International Carriage of Perishable Foodstuffs and on the Special Equipment to be Used for such Carriage (ATP)