Temperature Compliance
ALL-SEASON TEMPERATURE CONTROL FOR QUALITY ASSURANCE
While we can’t control the weather, Accuristix can manage and monitor the temperature of your products and ensure compliance with all aspects of the revised Guidelines for Environmental Control of Drugs during Storage and Transportation (GUI-0069).
Controlling temperature exposure during transportation is a critical component of GUI-0069 compliance. Even minor variations in temperature can affect the quality of the drug, cause medications to become ineffective or completely spoil a product.
The Quality Assurance & Compliance team at Accuristix has invested extensively in environmental control management to help overcome the many challenges that GUI-0069 brings to your products. Our Temperature Services include calibration, validation, shipping container qualification, product stability, cycling, vibration and transportation lane studies. We also have comprehensive transportation temperature data for destinations across Canada.
Our comprehensive temperature studies include:
Mapping temperature variations within all the areas where temperature sensitive products may be stored or temporarily held during transit (e.g., warehouses, packing areas, loading bays, cold and freezer rooms)
Documenting high and low temperature fluctuations that may be caused by environmental control systems (e.g., heating, cooling and ventilation)
Identifying potential issues that may cause temperature variations
Proposing the best places to locate or re-locate temperature sensors
Understanding how seasonality and different transportation modes can impact product temperature exposure
Recommending any remedial actions needed to overcome issues identified
With our 16 cu.ft. environmental chamber, we can offer shipping container testing capabilities through temperature and humidity cycling. Accuristix can design and test a shipping container to meet your product labelled conditions and GUI-0069 requirements. This chamber also allows us to calibrate temperature sensors and loggers.
GUI-0069 Compliance
GUI-0069 states that companies must transport, handle and store drugs in a way that reduces the risk of exposure to temperatures outside the labelled storage conditions (i.e., reduce the risk of “temperature excursions”).
The revised guidelines assign responsibility for GMP and GUI-0069 compliance to all parties involved in the supply chain (product owners, 3PLs and carriers).
When products are shipped across Canada, they can experience environmental conditions that vary greatly depending on the time of year and location. Despite these wide variations, Health Canada requires the temperature of drugs while in-transit, be maintained at levels consistent with product labelling.
How you can ensure compliance with GUI-0069:
Conduct transportation lane studies considering your distribution network, transportation modes and seasonality
Rely on product stability and cycling studies to assess impact of temperature extremes
Consider impact of other environmental conditions such as vibration
Use a qualified shipping container when necessary
The in-house expertise of our QA & Compliance team can help you overcome the many challenges that GUI-0069 brings to your business.