Hardware and web applications meet the requirements to support customers that store and transport pharmaceuticals throughout Europe
Rochelle Park, NJ - ORBCOMM Inc. (Nasdaq: ORBC), a global provider of Machine-to-Machine (M2M) and Internet of Things (IoT) solutions, today announced that it 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 computerized systems, that support Good Distribution Practices (GDP) of pharmaceutical products for human use.
Following a thorough audit by EIPL as well as several pharma customers, ORBCOMM’s processes, procedures and documentation for select temperature recorders, modules and cold chain monitoring solutions have been approved to meet the GAMP 5 guidelines for the European market. This approval confirms that these ORBCOMM cold chain compliance products are a reliable and cost-efficient choice for customers 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 of Global Sales. “By utilizing 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.”