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.
Almac Pod™ White paperIn 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.
Major Pharma Company implements FDA recommendations by employing Almac’s Temperature Management SolutionsDuring 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.
Large Pharma Company utilises Almac’s Excursion Management Solution to meet new GDP regulationsAs 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.
Next Generation Temperature ManagementAlmac’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 HandsAt 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.
Temperature Management – Keep Your CoolShipments 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.
Almac & Pharma Logistics IQ present the findings of their 2016 Temperature Controlled Logistics ReportGain 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.
