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

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

Course No 19558

This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager". Learn more.

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Dr Raphael Bar, BR Consulting, Israel
Dr Thomas Fürst, Boehringer Ingelheim, Germany


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 Live Online Training will address these aspects.

Target Group

This Live Online Training will be of significant value to
  •  Qualified Persons
  •  Quality Assurance personnel
  •  Pharmacists
  •  Project coordinators/product managers
  •  Stability testing personnel
  •  Stability program logistics personnel
  •  R&D personnel involved in product development

Technical Requirements

For our Live Online Training Courses and Webinars use Cisco WebEx, one of the leading suppliers of online meetings. At you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Overview of Stability Programs and Storage Statements
  •  Stability studies and development phases
  • Long-term and accelerated storage conditions of new drug substances and products (EU, USA)
  • Stability storage programs for generic drugs (EU, USA)
  • Specific storage statements (EU, WHO, USP)
  • Labeling statements for various pharmaceuticals
Mean Kinetic Temperature (MKT) and World Climatic Zones
  •  Mean Kinetic Temperature (MKT) and relative humidity
  •  Interpretation of MKT
  •  MKT from temperature loggers
Q&A Session I

Stress Studies of Pharmaceuticals
  •  Degradation reactions
  • Stressing factors and conditions
  • Stress studies in the pharmaceutical industry
Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals
  •  Stress testing vs Forced Degradations
  •  Studies at elevated extreme temperatures
  •  Studies at low extreme conditions
  •  When, how and what?
  •  Thermal Cyclic studies
  • What attributes to test
Q&A Session II
Investigation of Excursions from Storage Label Conditions
  •  “Time-out-of-Storage” and stability budget“ concept
  •  Handling an excursion
  •  What stability data are required to investigate temperature excursions
  •  Responsibilities of manufacturer, distributor and QP
Evaluation of the Impact of Temperature Excursions
  • Estimation of the impact by the excursion temperature on the quality attribute
  • Estimation of the quality attribute at the end of shelflife/retest date
Q&A Session III

Three Q&A sessions ensure interaction and that your questions are answered.

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