The general purpose of temperature management is to:
“ensure that pharmaceutical products are consistently stored, transported & handled under suitable conditions as required by the marketing authorisation or product specifications”
With an increasing number of biologics and biosimilars in development, management of the complete supply chain for investigational products requires a complete solution.
Updated Good Distribution Practices (GDP) have raised the awareness around temperature management of pharmaceutical products and caused a stir within the industry. The changes to regulations have put increased pressure on sponsors to demonstrate compliance in regards to shipment and storage of all products, not just cold chain, but throughout the temperature-sensitive supply chain.
There is an increased level of scrutiny around temperature excursion decisions, how the process is managed and how decisions are communicated and documented. Previous industry standards that were used for ‘ambient’ material may no longer be acceptable in the latest version of the guidelines. Sponsors are now faced with the difficult challenge of determining where they have gaps and implementing a cost-effective compliant solution.
Almac has designed a suite of service offerings to manage temperature controlled products and provide assurance to our clients that their products are monitored, every minute, from manufacture to patient administration.
Tracking In-Transit Temperature (Click to Read More)
- Program temperature monitors for shipment and collect the data from these monitors using STEMS
Adjudication of shipment excursions (Click to Read More)
- Collect all data necessary to make a decision (e.g. temperature data, shipment, facility, and site details, contents of shipment)
- Make a decision on the acceptability of the drugs using guidelines provided by sponsor
- If necessary arrange for the material to be replaced
Adjudication of excursions that occur at the clinical sites (Click to Read More)
- Collect all data necessary through communication directly with the clinical site to make a decision (e.g. temperature data, facility, and site details, contents of refrigerator)
- Make a decision on the acceptability of the drugs using guidelines provided by sponsor company
- If necessary arrange for the material to be replaced
Compliance Management (Click to Read More)
- Ensuring sites download the temperature monitors by sending protocol specific alerts to sites
- Alerts can be event or calendar driven and can include CRA/monitors, client etc
Comprehensive GDP Monitoring - also referred to as End to End Monitoring (Click to Read More)
- 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 (manufacture → receipt → production→ storage at Almac and depots→ distribution→ storage at clinical sites) using stability data provided by sponsor
- Oversight and guidance provided by Almac pharmacists
Click here to view Almac’s Webinar on ‘Temperature Surveillance for GDP Compliant Clinical Trial Supply’
Cold Chain Management
Cold Chain Management
Packaging, labelling, storing and distribution of temperature sensitive investigational products
We have taken a number of proactive approaches to provide an industry-leading service in this area, implementing effective management of your valuable products throughout the cold chain.
- Investment in facilities- significant packaging, labelling and storage capacity expansions in our EU, US and Asia facilities
- Dedicated temperature and humidity controlled labelling suites (36-46°F)
- Automated and semi-automated label applications for vials, ampoules and syringes
- Specialist cold chain teams to work with clients, couriers and shipper companies, managing the cold chain globally and providing specialist analysis on a protocol-by-protocol basis
- Implementation of 96 hour pre-qualified shipping systems
- Shipping Temperature Electronic Monitoring System – STEMS
Our Shipping Temperature Electronic Monitoring System
In response to the increase in biologics in the marketplace, we have developed STEMS, our very own web-enabled, fully validated, data management system for temperature sensitive shipment information. This exclusive system is fully customised for clinical trial shipments and enables users to see each of their crucial shipment temperature reports upon monitor upload.
STEMS provides real-time notifications of shipment results and immediate on-line access to the temperature data essential to the management of drug supply. Online data access and real-time decision making on a global scale reduces quarantine times for trials where the time from shipment receipt to dispensation to patient is limited.
Another area where STEMS is ideal is trials, during which the archiving and retention of temperature data is critical for future regulatory submissions. Trials conducted in countries where the return of temperature monitoring devices is a complex or lengthy process will also benefit, as users can make instant decisions 24 / 7 on their clinical supplies, without the need for monitor returns or the faxing of results.
Key Features and Benefits
- Instant report access
- 100% shipping temperature report
- 21CFR Part 11 compliant and fully validated – closed validated system
- No return shipments required for devices
- Compatible with various devices
- User friendly
- Automatic email notifications
- Web-based application
- Improved tracking and electronic archiving
- Instant knowledge of shipments with excursions
- Crucial decisions can be made instantly
- Near zero quarantine time – improved inventory management
- Streamlined process allows 100% recording of results
- Integral root-cause analysis tool
- Enables KPI extraction
- Provides basis for process improvements
- There is no manual input of information from shipment to dispatch to temperature report review – this creates a closed, reliable system
- Can be configured to work with any device
- Error resistant and paperless
- Can be accessed anywhere with internet access including mobile hand-held devices
- Used with a range of browsers IE Explorer, Mozilla Firefox, Opera and Safari
High quality, customised, prequalified shipping solutions
We recognise the importance of the safe delivery of temperature sensitive medicinal products. That’s why we’ve customised a range of high quality, tailor-made, prequalified shipping solutions that ensure thermal stability for your temperature sensitive products, even in extreme temperatures.
Our systems cover 98% of our shipping requirements – the rest are covered using active temperature controlled systems and temperature controlled trucks. We also offer, in conjunction with our partners, full shipping unit customisation to any set of specifications and we will provide advice on any important factors that may need prior consideration.
Key features include:
- Excellent thermal insulation for precise temperature control
- Shock resistance to protect your product during shipping
- 96 hours pre-qualification
- Flexible range of sizes tailored to suit the product and distribution requirements
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. In line with GDP guidelines the Almac Pod™ temperature controlled shipping solution, 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.
Click here to find out more.