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GMP Training – GMP for Warehouse by www.gmpsop.com
where problems would most likely be encountered, e.g., storing goods against
north-facing walls, close to room heaters, close to windows or near the roof.
After initial mapping, temperatures are routinely monitored on a continuous or
daily basis. This monitoring may reveal seasonal patterns where temperatures
may rise or fall outside approved limits. It is important, then, to continue to
review temperature profiles in the warehouse over time, particularly during
summer and winter. Some companies monitor using an electronic building
management system.
AMBIENT TEMPERATURE STORAGE
The terms "room" or "ambient" temperature storage conditions have different
meanings to different companies and different regulators. It is now more
common the use the term "temperate" storage. Temperate storage has recently
been redefined as a storage temperature of between 15°C and 30°C, with
occasional excursions above that range.
Temperate storage controls vary from product to product, however, many
licensed products stipulate an upper limit of 25°C with no lower limit apart
from "protect from freezing". Inspectors have indicated that 8°C to 15°C is
acceptable temperate storage.
ADDITIONAL REQUIREMENTS FOR TEMPERATURE CONTROL
The conditions of storage for the goods should be compatible with the
storage conditions specified on their labels.
Controlled storage environments should be monitored, using suitable
temperature recording devices. All records should be reviewed and filed,
with their results tabulated and analyzed.
Refrigerated and freezing storage environments should be fitted with both
an alarm and a visual signal. This signal should permit resetting only by an
authorized person,
If any temperature is found to have deviated outside the relevant
recommended conditions for an extended time, the manufacturer of the
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