How Life Sciences Organizations Can Easily Control Material Temperature with AX for Pharma

On October 26, 2022

In the pharmaceutical and biotech industries, it is crucial to store temperature-sensitive raw materials, active ingredients, and products in temperature-controlled areas such as cold rooms, refrigerators, or freezers. Therefore, it is necessary for any enterprise resource planning (ERP) system to create and control variables such as temperature and humidity.

Additionally, Life Sciences companies must ensure that radioactive materials, narcotics, hazardous, toxic and/or explosive materials are properly segregated in specific areas with appropriate safety and security measures. They must be able to track any movements in and out of these locations within the ERP system.

The handling of temperature-sensitive products is regulated by different requirements across the world such as FDA 21 CFR 203.32 “Prescription Drug Marketing – Drug sample storage and handling requirements” or ICH Q1A (R2) “Stability testing of new drug substances and products”.

The AXP365 Advanced Warehouse ManagementTM solution help enforce those guidelines and prevent the storage of critical material in inadequate locations.

In AX for Pharma 365™, it is possible to:

  1. Configure storage conditions and define their acceptable ranges (e.g. temperature from 2 °C to 8 °C, humidity up to 20%, etc.)
  2. Configure storage attributes that reflect the characteristics of dangerous items and the requisites needed for their storage (e.g. flammable, toxic, explosive)
  3. Assign storage conditions and/or attributes to products and to warehouses or locations
  4. Implement an approval process to create and maintain storage conditions and attributes, which can be secured through electronic signature
  5. Print the product storage condition and/or attributes on inventory labels, or acquire the information from a mobile device by scanning the product identification number
  6. Receive a warning or error message every time an item is placed in a location that is not compliant with its storage conditions and/or attributes
  7. Print a report that displays all the material stored in locations with incorrect storage conditions and/or attributes (e.g. a batch of temperature-sensitive material mistakenly stored at room temperature)
  8. Configure the system to prevent movements into specific areas according to the batch disposition code (i.e., quality status) of each lot. For instance, it is possible to block the movement of quarantine material into a production room.

Improve Your Storage Conditions with AX for Pharma 365™

The AXP365 Advanced Warehouse Management TM solution ensures your materials are properly stored and enforces controls on inventory movements based on storage conditions and/or attributes. Contact AX for Pharma today to learn more.