What elements need to be considered when implementing a strategy to achieve best practices and meet all the obligations of the new regulations when storing temperature sensitive pharmaceutical products?

What elements need to be considered when implementing a strategy to achieve best practices and meet all the obligations of the new regulations when storing temperature sensitive pharmaceutical products?

The following 4 main elements need to be considered to achieve best practices and compliance with new cold chain management regulations; 
  1. Equipment - Storage areas (inter alia cold rooms, refrigerators and freezers) must be capable of storing pharmaceutical products within the correct temperature range in all areas at all times.  Temperature monitoring and data collection needs to be automated to accommodate a minimum of 10 minute sampling in multiple areas within the storage space at all times.
  2. Temperature Mapping Study - A temperature mapping study is required once a year to confirm that temperature sensitive pharmaceutical products can be stored safely within all areas of the storage area at all times.
  3. Calibration – all temperature sampling equipment must be calibrated annually to a traceable and certified standard.
  4. Compliance reporting – Alarming, notifications, data storage and reporting to manage medication quality and provide traceability to ensure compliance with the regulations and ensure patient safety.

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