Compliance with the appropriate storage and transportation conditions for medicinal products is vital in ensuring its quality.

Shelf life dates are based on ideal storage conditions. Therefore, the protection of the quality of the goods until the end of the shelf life is very important both in terms of working with customers and saving resources.

 

GMP/GSP (Good Storage Practice) requirements for monitoring of storage conditions:

  • 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 be calibrated at defined intervals.

The transportation of medicinal products shall be handled in such a way as to maintain the quality of medicinal products. Unsuitable temperature, humidity, lighting and other conditions shall be avoided.

To maintain the quality of thermolabile medicinal products, the required temperature levels shall be maintained during the entire period of transportation. The temperature conditions during the period of

transportation shall be checked upon delivery.

The UNITESS AMBIENT monitoring system consists of software and a product line that completely covers the task of monitoring the conditions of storage and transportation of medical products.