Post-Conference Session: Stability studies to support shipping/distribution of Pharmaceuticals and Biopharmaceuticals
Im Auftrag der ECA Academy

1 December 2017

Vienna, Austria

Seminar Nr. 16229

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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

Overview of qualification of shipment of pharmaceuticals and Temperature Monitoring

The four Qs: DQ, IQ, OQ and PQ
Temperature monitoring in a shipment

World climatic zones and Mean Kinetic Temperature (MKT)

Mean Kinetic Temperature (MKT) and relative humidity
Interpretation of MKT
MKT from temperature loggers
Global climatic zones by ICH and WHO

Storage label statements (EU and USA)

Linking storage instructions to formal stability studies
Labeling statements for various pharmaceuticals (EMA guideline)
USP controlled temperatures

Stability studies to support shipping/distribution of pharmaceuticals and
biopharmaceuticals

Studies at elevated extreme temperatures
Studies at low extreme conditions
When, how and what?
Thermal Cyclic studies
What attributes to test

Investigation of excursions from storage label conditions

Handling an excursion
What stability data are required to investigate temperature excursions
Responsibilities of manufacturer, distributor and QP

Evaluation of Temperature Excursions

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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Post-Conference Session: Stability studies to support shipping/distribution of Pharmaceuticals and BiopharmaceuticalsIm Auftrag der ECA Academy