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.
Learn from our years of experience. Access our Temperature Management library today.
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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 Sharon Courtney as she discusses Almac’s Next Generation Temperature Management Services
Almac has a suite of temperature management services to optimize 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.
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 recognized 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.
Almac Pod™ White paper
In line with GDP guidelines our exclusive to Almac, temperature controlled shipping solution, the Almac Pod™, offers a Protected, Optimized 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.
New temperature management strategy ensures GDP compliance and patient safety for large pharma company
Download our case study to find out how the Almac Clinical Services team and Almac’s industry leading software, TempEZ™, intervened and drastically improved the sponsor’s temperature data collection.
Large Pharma Company utilizes 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.
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.
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 organization?
• 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 optimizing temperature controlled logistics?
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
Webinar: Developing an effective system integration to improve temperature data management
This webinar will focus on how system integrations such as Almac ONE, can improve your temperature data management and help mitigate the risks that can lead to negative patient impact and compromise study timelines.
Key Learning Objectives:
• Understand the fundamentals of mitigating the risks of temperature excursions
• Learn how to effectively develop system integration to promote robust temperature control
• Identify the benefits of managing temperature management risk with supply chain system integration
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.
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, Optimized 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.
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.