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In each supply chain step, there are unique challenges to consider. Look at these issues, and prevent problems before they arise.


Active Pharmaceutical Ingredients (API) Supply


APIs are shipped inbound to good manufacturing practice (GMP) production facilities from the market authorization holder’s (MAH) facility or another API supplier. Typically, large amounts of APIs are shipped with a very high product value. The bags, drums, or vessels are then stored until they are combined with excipients (non-medicinal components) to form the final drug. What if the temperature deviates during storage? Would that time out of refrigeration (TOR) be carried over to when the product is manufactured? Probably not. Usually a new stability budget begins the moment the final product leaves the fill/pack line.


APIs Come in Different Forms:

  • Liquid ingredients transported frozen, cryogenic, or refrigerated
  • Lyophilized ingredients transported deep-frozen, typically on dry-ice
  • Small molecule powder (sensitive to temperature and humidity) transported in bags or drums

These large bulk shipments are often transported via truck, ship, or plane to a distribution depot or regional distributor. Because of API sensitivities, special containers, logistical means, and monitoring solutions are necessary to protect APIs from unfavorable temperature and humidity. One temperature data logger is commonly used for one handling unit containing various products (with individual stability budgets).


This can cause problems later if there is an alarm in a multi-product shipment. How is each product released?


The solution: a cold chain database. Use a kit or box-level monitoring solution (e.g., electronic indicator) to carry over the total TOR of each product during storage and transport.


6177119fc30a8_4_1_2 Making the Right Cold Chain Logistics and Packaging Choices for Your Products-Dec-16-2021-11-15-47-17-AM

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The second transport leg is often in the hands of a regional organization, which might not have the same access to resources and solutions. The shipments are often consolidated from different pallets, deliveries, or batches.


The problem then is how to carry forward the remaining stability (or the total TOR) from the previous transport leg?


The solution: a cold chain database.


After filling, a drug is in its final primary packaging (blister package, vial, respirator, or syringe), equipped with all its required leaflets inside a cardboard box, in a sales unit. This sales unit will now start its journey through the distribution depots to its final destination.



Last Mile


In the last mile, the challenge becomes even more difficult. Sales units are frequently divided, and the single doses are stored in hospital pharmacies, doctors’ offices, and even home refrigerators. How can the temperature history of the cold chain shipment be reconstructed?


How much total TOR has the product experienced vs. how much stability budget was initially available?


The solution: a cold chain database.


618068b330e9f_Preview Warehouse Qualification

Warehouse Qualification 


Elaborating the qualification process—from start to finish






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