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 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.
This Live Online Training will be of significant value to
- Qualified Persons
- Quality Assurance personnel
- Project coordinators/product managers
- Stability testing personnel
- Stability program logistics personnel
- R&D personnel involved in product development
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT 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)
- Labelling statements for various pharmaceuticals
Mean Kinetic Temperature (MKT) and World Climatic Zones/Uses and Misuses of MKT
- Mean Kinetic Temperature (MKT) and relative humidity
- Interpretation of MKT
- MKT from temperature loggers
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
Cycling Studies: Case Study
Excursions during Shipping and Distributions
- “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
Handling of Excursions: Case Studies
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
Four Q&A sessions ensure interaction and that your questions are answered.