Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals - Live Online Training

This Live Online Training will give an overview of tools that a Qualified Person (QP), Quality Assurance personnel or a Product Manager/Manufacturer should have in order to evaluate the impact of excursions from the storage label instructions on the disposition of distributed shipments of pharmaceutical/biopharmaceutical products.

The formal stability studies of pharmaceuticals and biopharmaceuticals are a well-established discipline and they are regularly conducted at precisely monitored conditions of temperature (within 2 °C) and of humidity (within 5% RH) under cGMP. However, the inevitable processes of shipping and distributing medicines from the manufacturer to wholesaler to warehouses to the end user via air, ship or car exposes often the shipments to temperatures and humidity different from the label storage conditions. For instance, how would you handle a shipment that was exposed to a varying temperature up to 61oC in the airport for an accumulated duration of several days? How would you evaluate the quality of a refrigerated injectable that was exposed to near zero or freezing temperatures for a few hours? Would you release or reject such a shipment which may cost hundreds of thousands of dollars?

Shipping/distribution of a medicine is considered a “mobile storage”. However, a temperature excursion outside the label instructions may also be considered a ‘trauma” inflicted on the medicine and this may impact the quality of the newly arrived shipments. But, the big question remains: how would that ‘trauma” affect the quality at the end of the declared shelf life of any pharmaceutical and of a biopharmaceutical in particular? Will the long-term impact lead to a “hidden OOS”? This training will address these aspects. In addition, the course also includes two case studies and a session with video presentations. Further, a set of Q&A sessions will follow the lectures. Thus, take advantage of this opportunity to pose your questions.

Wednesday, 10 September 2025 from 09.00 – 17.00 h CEST
Thursday, 11 September 2025 from 09.00 – 13.00 h CEST

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