LATEST HEALTH CANADA GUIDELINES >
By Shawn Siegel, Cold Chain IQ
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
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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: