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GUI-0069 Compliance
The long-awaited revised Guidelines for Environmental Control of Drugs during Storage and Transportation (GUI-0069) has been released.
GUI-0069 now states that:
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Temperature is one of the most important parameters to control
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You 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”)
Fill out this form to download our GUI-0069 white paper.
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 still requires the temperature of drugs while in-transit, be maintained at levels consistent with what is described on the product label. Use of Mean Kinetic Temperature (MKT) is allowed for temperature monitoring only and must be done in accordance with recognized pharmacopeia.
While the product is travelling, it may be exposed to temperatures outside the range described on its label. Transportation in temperature-controlled conditions may not be available for part of the journey or if you use a courier type carrier, not be available at all. As a result, the product could experience temperature excursions.
How you can ensure compliance with GUI-0069:
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Conduct transportation lane studies considering your distribution network, transportation modes and seasonality
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Rely on product stability and cycling studies to assess impact of temperature extremes
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Consider impact of other environmental conditions such as vibration
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Use a qualified shipping container when necessary
The Quality Assurance & Compliance team at Accuristix has invested extensively in environmental control management. Our in-house expertise can help you overcome the many challenges that GUI-0069 brings to your business.