Page 30 - GMP for warehouse
P. 30
GMP Training – GMP for Warehouse by www.gmpsop.com
For a successful cold storage operation, the facility must select the right
temperature recording instrumentation, validate its processes, and maintain
documentation of records and procedures, including responding to alarm
conditions.
INSTRUMENTATIONS
The selection of recording instruments is vital. The
instruments must be easily read, and the data
must be retrievable. The instruments must be
calibrated to a national standard (the company
should retain a copy of the calibration certificate
for the equipment), and a high/low temperature
alarm should be incorporated. Max/min
thermometers are usually not acceptable.
Both air and product temperatures should be
recorded. Note that air temperature can fluctuate
considerably more than product (often called
"load") temperature.
VALIDATION
Validation efforts must:
Prove that temperature mapping checks for
areas of extreme temperatures.
Check on temperature variations during use.
Demonstrate performance in the event of a
power failure.
Demonstrate the function of alarms.
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 30 of 64
