Sprecher
Dr Raphael Bar, BR Consulting, Israel
Zielsetzung
This session will give a comprehensive 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.
Hintergrund
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 61°C 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 course will address these aspects. Finally, a workshop will demonstrate how the evaluation of an example of a temperature excursion may be approached
Workshop
Evaluation of a Temperature Excursion in shipped refrigerated drug product.
Programm
Overview of stability programs and Stress Testing– regulatory view (GMP and GDP)
- Long-term and accelerated storage conditions of new drug substances and products (EU, USA)
- Stability storage programs for generic drugs (EU, USA)
- Stress testing vs Forced Degradations
- Stressing factors
- GDP Guides (EU, WHO, USP Chapter <1079> )
- “Time-out-of-Storage” and “stability budget“ concept
- The four Qs: DQ, IQ, OQ and PQ
- Temperature monitoring in a shipment
- Mean Kinetic Temperature (MKT) and relative humidity
- Interpretation of MKT
- MKT from temperature loggers
- Global climatic zones by ICH and WHO
- Linking storage instructions to formal stability studies
- Labeling statements for various pharmaceuticals (EMA guideline)
- USP controlled temperatures
biopharmaceuticals
- Studies at elevated extreme temperatures
- Studies at low extreme conditions
- When, how and what?
- Thermal Cyclic studies
- What attributes to test
- Handling an excursion
- What stability data are required to investigate temperature excursions
- Responsibilities of manufacturer, distributor and QP
- Estimation of degradation rates at the excursion temperature
- Estimation of degradation at the expected long-term shelf-life
- Estimation of a maximal “Time-out-of-Storage” of a drug
This post-Conference Session ideally complements the ECA education courses
“Setting Specifications” (28-29 November 2017 in Vienna, Austria)
and
“Stability Testing of Drug Substances and Drug Products”
(29-30 November 2017 in Vienna, Austria).
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