Cold Chain GDP Services

  • Cold Chain temperature monitoring is a vital, yet time consuming part of a larger supply chain organization. As practitioners in the industry for nearly 30 years, ELPRO has the experience to help you each step of the way implementing a new data monitoring system, a central database, or running the project by facilitating training, inventory management, alarm analysis and report generation for your cold chain.
The world is a busy place. Especially in multi-national pharmaceutical companies with global commercial or clinical supply chains – often with constrained resources.

ELPRO is here to help. We will be with you every step of the way from project design to ‘go live’. If you would like additional support after the project is launched, our experienced and qualified experts assist you in on-going project management services through to complying with GDP requirements.

Valuable statistics to improve transparency of your supply chain
But how do you get the statistics? Why are they important? In interviews, ELPRO customers outlined the value of modern data monitoring systems. Today is not just about collecting temperature data but how it’s used with other logistics, transport and quality information. By putting together the shipment tracking information from the freight forwarders with the temperature records, the graphic starts to have a meaning and tell the story of the transportation route, enabling you to identify the root cause for the excursions, and to determine the corrective and preventive actions, e.g.: changing transport mode, improving packaging solution, warehouse, freight forwarding agent or service.

Let ELPRO take your anxiety away and walk you through the transition, step by step. We can show you what’s possible having a central repository of temperature data. Using the years of experience with large multi-national pharmaceutical companies, we will show you how to identify trends in your supply chain and uncover cost-saving improvements.

Project Management Services:
Alarm Analysis

If your resources are limited, ELPRO can help by receiving alarm notifications, triage reports and determine root cause. If valid alarm, your QA or project manager will be notified to take a final decision. If not valid, due to human error for example, ELPRO can complete an "Assessment Report" in elproVIEWER expediting shipment release. We can then upload report, update the database, generate time of storage report and notify your QA for review.

Report Generation
It is a wasted opportunity if you have all of your shipment’s temperature data, but don’t have the time to run reports to monitor the performance of your temperature controlled supply chain, your logistics partners and CROs. ELPRO can help by acting as the human interface between the liberoMANAGER database and your operations. We can run customer defined regular reports on activities such as: total alarms per lane / or per study / molecule; alarms by carrier or type of packaging; how many ‘open shipments’ to a clinical site or certain study… really any information you have indexed in your liberoMANAGER database.

Training
With years of experience implementing global data monitoring systems, it has been proven that the more successful training is with your customer staff, CROs, CMOs and clinical sites; the more successful the project outcome will be. We have used various tools to get the job done… well. Using WebEx, online tutorials and customized videos per your SOPs; ELPRO makes sure your temperature monitoring project is launched smoothly.

Inventory Management
ELPRO can send rolling reports on data loggers ordered, shipped to which destination / CRO / 3PL including shipment or study number and which profile was used. This type of visibility enables you to have optimal data logger inventory at all times ensuring your cold chain and clinical studies continue to be on time.

GMP Services for GDP Applications:
Lane analysis and transport qualification

Understanding the performance of certain shipping lanes or certain packaging solutions is imperative to an efficiently run cold chain, as well as required under GDP regulations. ELPRO can establish risk-based protocols for validating your temperature control processes for certain products within a particular shipping lane. Our validation experts can conduct GDP compliant periodic reviews with you on an annual basis, complementing regular quality review activities.

Facility qualification for warehouses and cold chain storage areas
ELPRO's GMP Services offer a comprehensive service package for a complete qualification of pharmaceutical storage units, including an assessment of the risk involved in the storage process, working through qualification steps from DQ to PQ, and writing the final report.

Thermal Mapping
Do you need to understand the performance of your distribution storage facility, cold and hot spots? ELPRO’s Thermal Mapping Service is a simple, efficient way to obtain a GMP-compliant mapping report. No need to buy data loggers, no special software, and a minimum of time and resources. Regardless of your location, we don’t need access to your site and no one needs to travel.

→ Read more about GMP Services

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