The Latest on Health Canada Guidelines

Canada is playing an increasingly large role in the biopharma industry following a recent surge in investment. This rise in prominence is taking place along with the global growth in the biopharma cold chain. Various reports estimate that the global cold chain market will grow at an annual rate of 10-15% (depending on the report) over the next five years. This rise is in large part due to the rapid growth of emerging markets, but also due to a new focus on biologics and clinical trial materials that rely on temperature controlled transportation.

To match these changes, regulators around the globe are adjusting their GDP guidelines. This year, Health Canada began its 3 year cycle of updating its Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069). These guidelines came into force on April 28th, 2011, superseding the guidelines originally released in October of 2005. (Download the Guidelines).

The additions introduced in GUI-0069 built on the good practice that has formed
around the distribution of temperature controlled pharmaceuticals, in part as a result of the greater emphasis being placed on the growing biopharmaceutical and life sciences industries.

According to WT100, the newest proposed guidelines from earlier this year do not add new obligations, but mostly go into greater depth about monitoring and supervising existing practices. Some of the most important revisions include:

• Shippers and carriers need to have contingency plans in case of delays. These plans must include corrective actions and specific timeframes.
• Logistics providers should sign quality agreements. This follows a general industry-wide trend in the use of quality agreements, although Sarah Skruce, Compliance Specialist with Health Canada, says that transportation providers are still reluctant to sign quality agreements.
• There are new packaging guidelines including handling requirements being affixed to containers, as well as labels being affixed to individual boxes.
• New guidelines about employee training.
• New recommendations about temperature mapping.

According to Skruce, Health Canada plans a Q&A document for their website and a new guide on written agreements with transportation providers. There will be separate guidance focused on counterfeit products as well Active Pharmaceutical Ingredients.

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