Page 29 - GMP for warehouse
P. 29
GMP Training – GMP for Warehouse by www.gmpsop.com
goods should be contacted and the suitability of the product for use
resolved.
Equipment used for monitoring temperature should be calibrated on a
regular basis to ensure their accuracy.
How to create a temperature map
A simple temperature control example involves the physical location of material
storage in the warehouse. The higher up in the warehouse a material is stored,
the hotter the temperature the goods will be exposed to, so a physical space
nearer the ceiling without temperature controls will be inappropriate to store
goods that need to be kept cool.
Study the temperature profile of the premises, and identify potential "hot"
and "cold" areas.
Study the areas of greatest potential risk using calibrated temperature and
humidity monitoring instruments.
Develop a temperature mapping validation protocol.
Based on initial findings, commence monitoring on a regular basis.
Produce a temperature map of the premises.
Review the hot and cold areas when outside temperatures are extreme, for
example, in summer and winter.
Review the controls of heating and cooling systems.
Ensure an action plan exists in the event of temperatures becoming
compromised.
Cold storage
Cold storage refers to the storage of products requiring a storage temperature of
2°C-8°C, or when material is required to be stored frozen (e.g. below -20°C or
below -70°C).
Copyright©www.gmpsop.com. All rights reserved
Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited.
Page 29 of 64