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

7/8 September 2023

Course No 20556

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

All times mentioned are CEST.

Our Service

Costs

*ECA-Member:**	EUR 1690,--
*Non ECA Member:**	EUR 1890,--
*EU/GMP Inspectorates:**	EUR 945,--
*APIC Member Discount:**	EUR 1790,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

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

Objectives

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.

Background

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.

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

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.

Programme

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

Video Presentations

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.

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