Temperature Services

Temperature Services

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Adjudication of In-Transit and Clinical Site excursions

  • Collect all data necessary to make a decision (e.g. temperature data; shipment, facility and site details; contents of shipment or refrigerator)
  • Make a decision on the acceptability of the drugs using stability guidelines provided by the sponsor company
  • Update the Interactive Response Technology (IRT) with the result of the adjudication
  • If necessary, arrange for the material to be replaced

Compliance Management of Shipments

  • Ensuring sites upload the temperature monitors by sending protocol specific alerts to sites
  • Alerts can be event or calendar driven by the shipment and can include CRA/monitors, client etc.

Compliance Management of Sites

  • Regular review of the site storage logs against reported site excursions
  • Expedited processing of any unreported excursions to determine material acceptability
  • Review of patient dosing for unreported excursions

Comprehensive GDP Monitoring (also referred to as End to End Monitoring)

  • At a lot or med ID level, collection of temperature deviations from manufacture through dispensing to the patient
  • Evaluation of cumulative deviations across all activities using stability data provided by sponsor
    (manufacture ➝ receipt ➝ production ➝ storage at Almac and depots ➝ distribution ➝ storage at clinical sites)

Expert in a Box

Listen to our leading expert on temperature management, Sharon Courtney, as she discusses our Next Generation Temperature Management Services.

If you would like further information on Temperature Services please get in touch with us.

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Next Generation Temperature Management Resources

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  • White Papers

  • Case Studies

  • Reports

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  • 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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