Orbcomm cold chain monitors achieve Gamp 5 validation
September 8, 2015
M2M satellite company Orbcomm’s Euroscan temperature recording devices and cold chain monitoring systems have been validated to the Good Automated Manufacturing Practice (Gamp 5) guidelines.
These 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.
The New Jersey based company has enhanced, tested and implemented the processes and documentation to demonstrate that the Euroscan product line can be validated by Gamp 5 guidelines. This validation confirms that the products are a reliable 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.
As part of this process, the products passed an audit by the European Institute for Pharma Logistics (EIPL) to support its compliance with Gamp 5 guidelines.
“We are pleased to receive confirmation that our products follow Gamp 5 methodology, which enables us to support our pharmaceutical customers in Europe at every point in the transportation path,” said Ron Quaedvlieg, Orbcomm’s managing director of Euroscan. “Orbcomm’s industry-leading cold chain solutions not only provide reliable temperature monitoring, fuel management, maintenance and remote control functionality for refrigerated assets, but also enable our customers to improve operational efficiency, enhance customer satisfaction and meet their regulatory requirements for quality assurance.”
Orbcomm claims to be the only commercial satellite network dedicated to M2M. The company can remotely track, monitor and control fixed and mobile assets in core vertical markets including transportation, distribution, heavy equipment, industrial fixed assets, oil and gas, maritime, mining, and government.