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IMPORTANT MESSAGE

Like many other companies and institutions around the world, we are experiencing interference with some of our systems within the TNT network.

We are implementing remediation steps as quickly as possible. We have implemented operational contingencies to continue to complete collections from customers with scheduled stops. For customers who do not have a regular stop, collection should be arranged via our customer service centers.

Customers may experience delays in the transit of shipments, particularly inter-continental or non-EU European delivery, as we work to remediate our systems. Additionally, if customers do not have the facility for self-labeling, they may also experience delays.

We are not able to collect shipments of dangerous goods at this time.

We regret any inconvenience to our customers.

TempEZ™

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TempEZ™ offers clients a single database to store temperature data from product manufacture to patient administration, as well as providing a platform to ensure compliance to cGXP and GDP regulations.

TempEZ™ is designed to upload temperature data from numerous monitor brands. It also allows any stakeholder in the client’s clinical or commercial supply chain to upload temperature monitor data and record planned and unplanned excursions at a lot or serialised level.

These features allow clients to use their preferred vendors and monitors.

High level features of TempEZ™ include:

  • Create and manage monitor profiles and product stability data
  • Program monitors
  • Register shipments (Almac and non-Almac)
  • Collect temperature data from in-transit and site monitors
  • Record, report and adjudicate in-transit and site excursions
  • Tracking of excursions at a lot or serialised level
  • Record planned excursions
  • Integration with IRT providers
  • Reporting and advanced analytics

Benefits of TempEZ™ include:

  • Temperature data from manufacture to patient administration is all in one place
  • Easy to use platform to support GDP compliance
  • Ability to build a complete temperature history for a product at a lot or serialised level
  • Controlled, quality approved process for adjudication
  • Ability to expedite the removal of out of specification drugs
  • Ability to run analytics across key performance factors and make changes to improve internal and vendor performance

Expert in a Box

Listen to our leading expert on temperature management, Heather Bogle, as she discusses TempEZ™, the next generation innovation from Almac.

 

Next Generation Temperature Management Resources

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TempEZ™ – GDP and GCP Compliant Temperature Monitoring Solution

TempEZ™ offers full visibility of your temperature data from any stakeholder within your clinical or commercial supply chain including numerous temperature monitor brands. Almac are first to market a single platform that links data from a monitor, shipment, drug product and stability data while providing a quality approved process for controlled adjudication and excursion decisions.

 

Listen to our leading expert Heather Bogle as she discusses Almac’s uniquely designed TempEZ™ platform

At Almac we understand your temperature control challenges. Our experts have developed an end to end regulatory compliant solution giving you full visibility of your temperature data on a single platform.

 

Listen to our leading expert Sharon Courtney as she discusses Almac’s Next Generation Temperature Management Services

Almac has a suite of temperature management services to optimise temperature management, for investigational and commercial products including, adjudications of in-transit and clinical site excursions, management of site compliance of shipments, management of compliance of sites and comprehensive GDP monitoring.

 

Listen to our leading expert Heather Bogle as she discusses Almac’s regulatory Temperature Management Services meeting the regulatory challenges of managing the Temperature data of your pharmaceutical products

With temperature controlled shipments continuing to increase, so have the regulatory demands of operational pressures on temperature management of investigational and commercial products. We provide a flexible and convenience solution, ensuring GDP and GCP compliance.

  • Survival Guide Thumbnail
  • A Survival Guide To Temperature Data In Life Sciences- White paper

    As the pharmaceutical industry is heavily regulated, the demand for quality and sound data collection is highly recognised across all companies. Now is the time for your company to take control of your temperature and stability data. Find out how in this informative white paper.

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  • White paper
  • Almac Pod™ White paper

    In line with GDP guidelines our exclusive to Almac, temperature controlled shipping solution, the Almac Pod™, offers a Protected, Optimised and Dynamic solution that safeguards customers’ product and mitigates against temperature excursions of all clinical shipments with advanced phase change technology – the perfect solution for Biologics or difficult to handle products.

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  • TEMPERATURE MANAGEMENT SOLUTIONS
  • Major Pharma Company implements FDA recommendations by employing Almac’s Temperature Management Solutions

    During a recent FDA clinical inspection of a major pharmaceutical company, the auditor placed a strong focus on temperature excursion tracking of study drugs, from manufacture of product through to storage at the clinical sites. The inspector recommended improving the timelines of excursion notifications to the sponsor and the comprehensive tracking of cumulative temperature excursions throughout their supply chain.

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  • GDP REGULATIONS
  • Large Pharma Company utilises Almac’s Excursion Management Solution to meet new GDP regulations

    As a result of updated GDP’s regulations, a large pharmaceutical company started including temperature monitors into a large percentage of their clinical site shipments. The purpose was to monitor the shipment payload’s temperature and determine if additional shipment controls were required. The company’s plan was to review the results and manage excursions based on predefined stability criteria.

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  • Temperature Controlled Logistics
  • Almac Group and Pharma Logistics IQ proudly present the findings of their 2016 Temperature Controlled Logistics: Strategies for the Future report, examining the future of the pharma cold chain logistics industry.

    Gain industry insight from industry leader Heather Bogle, Supply Chain Solutions Manager at Almac Group as she discusses the temperature services industry as a key priority for pharma, and find out where stakeholders in the international cold chain community stand on issues such as:

    • How important is it to strive towards being future proof as a temperature controlled logistics organisation?

    • What area will be the most damaging to your firm if you don’t adapt and innovate quickly?

    • What are investment plans over the next 12 months for optimising temperature controlled logistics?

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  • Temperature Surveillance
  • Webinar: Risk Management – Global Temperature Surveillance best practice for the Pharmaceutical Supply Chain

    This webinar provides an overview on how you can develop best practice and implement temperature management processes that will drive down/eliminate excursions, improve supply to patients and provide a better global supply chain for the benefits of all.

     

    Key Learning Objectives:

    • Understand the impact of GDP regulations on pharmaceutical supply chain

    • How to develop a risk management strategy

    • Understand how to manage temperature excursions across the complete product lifecycle

    • How in-country expertise can drive decision making

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  • Next Generation Temperature Management Solutions Thumbnail
  • Next Generation Temperature Management

    Almac’s Next Generation Temperature Management Solutions is a flexible portfolio of software, services and products, developed using our years of pharmaceutical and logistics experience. These solutions safeguard the quality and integrity of your intricate and fragile medicinal products, every step of the way.

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  • Almac Pod
  • Almac Pod™ – Your Product, Safe In Our Hands

    At Almac we understand the need for tailored and innovative solutions to safeguard your global clinical trial with assurance and reliability. The Almac Pod™ is an exclusive to Almac, superior shipper that delivers a Protected, Optimised and Dynamic temperature controlled shipping solution. The Almac Pod™ offers enhanced protection for your clinical shipments and is supported by advanced technology – the perfect solution for Biologics or difficult to handle products.

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  • TEMPERATURE MANAGEMENT - KEEP YOUR COOL
  • Temperature Management – Keep Your Cool

    Shipments may experience a range of temperature effects that can impact the stability of a product, leading to temperature excursions that cause the product to become unfit for patient administration.  Steps must therefore be taken to reduce the risk of these and to have the data to support adjudication of the product.  Learn more about these necessary steps in our informative ‘Temperature Management – Keep your Cool’ article, written by Almac’s Heather Bogle, which was recently published in the IPI (International Pharmaceutical Industry) magazine.

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