Orbcomm meets Gamp 5 for European cold-chain monitoring
September 28, 2016
Orbcomm has received the Good Automated Manufacturing Practice (Gamp 5) official certification of approval from the European Institute for Pharma Logistics (EIPL) for its Euroscan-branded product line of temperature recording devices and cold-chain monitoring systems.
Gamp 5 guidelines are published by the International Society for Pharmaceutical Engineering (ISPE) and provide a flexible, risk-based approach on how to define and implement quality procedures, including compliant computerised systems, that support good distribution practices of pharmaceutical products for human use.
Following a thorough audit by EIPL as well as several pharma customers, the New Jersey company’s processes, procedures and documentation for select temperature recorders, modules and cold chain monitors have been approved to meet the Gamp 5 guidelines for the European market.
This approval is said to confirm that these cold-chain compliance products are a reliable and cost-efficient choice for users that need to gain complete traceability of their operations, report storage conditions, including deviations in temperature settings, and protect the quality and integrity of their refrigerated assets throughout the European supply chain.
“Orbcomm’s Gamp 5 approval is a significant milestone in demonstrating the high-performance, integrity and reliability of our products and ensuring that our pharmaceutical customers in Europe achieve complete cold-chain compliance,” said Christian Allred, Orbcomm’s senior vice president. “By utilising our Euroscan-branded temperature recorders and web reporting applications, customers will improve their cold chain operations from end to end and gain total assurance of an uninterrupted cold chain from the product’s point of origin all the way to the end customer.”
Orbcomm combines global satellite, cellular and dual-mode network connectivity, hardware, web reporting applications, and software. It can remotely track, monitor and control fixed and mobile assets in core vertical markets including transportation and distribution, heavy equipment, industrial fixed assets, oil and gas, maritime, mining, and government.
With nearly 20 years of innovation and expertise in M2M, the company has more than 1.6 million subscribers with a diverse customer base including OEMs such as Caterpillar, Doosan Infracore America, Hitachi Construction Machinery, John Deere, Komatsu and Volvo Construction Equipment, as well as end-to-end providers such as C&S Wholesale, Canadian National Railways, CR England, Hub Group, KLLM Transport Services, Marten Transport, Swift Transportation, Target, Tropicana, Tyson Foods, Walmart and Werner Enterprises.