GSP/GMP requirements: 

  • Recorded temperature monitoring data should be available for review.
  • The equipment used for monitoring should be checked at suitable predetermined intervals and the results of such checks should be recorded and retained.
  • All monitoring records should be kept for at least the shelf-life of the stored material or product plus 1 year, or as required by national legislation.
  • Temperature mapping should show uniformity of the temperature across the storage facility.
  • It is recommended that temperature monitors be located in areas that are most likely to show fluctuations.
  • Equipment used for monitoring should also be calibrated at defined intervals.