[SatNews] ORBCOMM Inc. (Nasdaq: ORBC) announces that the company's Euroscan product line of temperature recording devices and cold chain monitoring systems is now fully validated to the Good Automated Manufacturing Practice (GAMP® 5) guidelines.
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.
ORBCOMM 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 ORBCOMM’s Euroscan products are a reliable 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. As part of this comprehensive process, ORBCOMM’s Euroscan products passed a thorough audit by the European Institute for Pharma Logistics (EIPL), to further support its compliance with GAMP 5 guidelines.
EIPL’s certification of ORBCOMM’s compliance to GAMP 5 guidelines is available upon request by contacting firstname.lastname@example.org.
“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.”