Temperature Management Solutions


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’