Informa Life Sciences is part of the Knowledge and Networking Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

08:30 - 15:30 420 mins
Main agenda
Successfully Handling Temperature Excursions and Using Stability Data to Support Product Shelf-Life during Transport and Shipping
  • Manuel Zahn - Managing Director, 3R Pharma Consulting GmbH, Germany

This interactive workshop will provide essential practical advice on managing temperature excursions and using stability data to support product shelf-life during shipping and transport.

Session 1

Basic Principles of Stability Testing

  • The Basic Principles of Stability testing - Part I
  • The impact of thermal energy on chemical degradation
  • Arrhenius equation / Arrhenius plot
  • Calculation of the degradation rate
  • Mean Kinetic Temperature (MKT)
  • Establishing a "Design Space" for storage conditions

A Systematic Approach to Stability Testing

  • Release vs. shelf-life specification
  • ICH Stability Guidelines
  • EU Stability Guidelines
  • Stability testing programmes for drug product according to ICH Q1A
  • Semi-permeable packaging material
  • Reduced stability testing: Bracketing & Matrixing (ICH Q1D)
  • Photostability studies
  • In-use stability testing
  • Ongoing stability studies

Basic Principles of Stability Testing - Part II

  • The impact of humidity
  • Partial and saturated water vapour pressure
  • Relative humidity
  • The Humidity Sensitivity Factor
  • Stability by Design

Session 2

International Regulatory Requirements

 Stability Testing for Zone III and IV Territories

  • The Climatic Zone Concept
  • Meteorological data
  • Consequences for long-term testing conditions
  • Global Testing Design

Regional and national Stability Guidelines and Where to Find Them

  • EU
  • USA
  • Canada
  • WHO
  • South Africa, Brazil, China, GCC

Session 3

Shelf-life estimation

 Statistical Analysis of Stability Data

  •  Stability studies supporting shipment and storage
  • The legal framework (GDP)
  • Monitoring shipment and storage condition
  •  Calculation of remaining shelf-life after temperature excursions