Stability Testing for Drug Substances and Drug Products (ICH Q1A)

Participants will learn about pharmaceutical stability guidelines, stress studies, submission requirements, and confirmation. They will discuss efficiency improvements, risk considerations, and potential design changes for stability testing.
  • Wednesday
  • October
  • 08
  • 2025
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
IMG Joachim Ermer
Webinar Id: 61281
Live
Session
$119.00
Single Attendee
$249.00
Group Attendees
Recorded
Session
$159.00
Single Attendee
$359.00
Group Attendees
Combo
Live+Recorded
$249.00
Single Attendee
$549.00
Group Attendees

Overview:

Establishing shelf life and suitable storage conditions for drug substances and drug products is an essential regulatory requirement and of utmost importance to maintain an appropriate quality, efficacy, and safety. Therefore, stability testing was the first topic of international harmonization (ICH-Guidelines Q1). The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of factors such as temperature, humidity, and light, to establish a retest period for the drug substances or a shelf life for drug products, long-term storage conditions, as well as label requirements (for drug product). Efficient management of the stability investigations throughout the product lifecycle has also a large economic impact.

Why you should Attend:

Participants will receive a basic overview on regulatory guidelines and expectations regarding the stability of pharmaceuticals across the lifecycle, from forced degradation (stress) studies in development, over stability data required for submission, to stability confirmation in the marked phase (on-going stability, changes). Possibilities to improve the efficiency of stability testing by bracketing and matrixing (reduced test design) and extrapolating the shelf-life are discussed, along with the risks to be considered.

Areas Covered in the Session:

  • Rationale for Stability Testing
  • Potential Quality Changes
  • Types of Pharmaceutical Stability Studies
  • Global Stability Guidelines (ICH, WHO)
  • Forced degradation (stress) studies
  • ICH Q1A (R2): Stability Testing
  • ICH Q1D: Bracketing and Matrixing
  • ICH Q1E: Evaluation of Stability Data
  • ICH Q5C: Stability of Biotechnological Products
  • Revision of ICH Series Q1A-F and Q5C 
  • Stability Guidelines – EU
  • On-going Stability Studies (Marketed Products)
  • Stability Guidelines FDA
  • Documentation

Who Will Benefit:

  • Analysts
  • lab supervisors and managers in Analytical Development and Quality Control responsible to plan, execute, or evaluate stability studies of drug substances or drug products
  • Quality Assurance and regulatory affairs representatives responsible to approve or evaluate stability data

Speaker Profile

Dr. Joachim Ermer is a biochemist with 30 years of experience in pharmaceutical analytics, including development products at Hoechst AG, global responsibilities as Director of Analytical Processes and Technology at Aventis, and head of Quality Control and head of QC Lifecycle Management Frankfurt Chemistry at Sanofi. From 2010 till 2020, he was also responsible for the central reference standard group and Global Reference Standard Coordinator of Sanofi. Since December 2020, he serves as consultant for topics of pharmaceutical analytics and Quality Control. Joachim Ermer is member of the USP Expert Committee “Measurement and Data Quality“, of the Ph.Eur. Working Group “Chromatographic Separation Techniques”, and Advisory Board member of the ECA Analytical Quality Control Group.

He authored more than 60 publications on analytical topics and contributed to the USP General Information Chapter <1220> as well as other Stimuli Articles. He is editor and author of the book “Method Validation in Pharmaceutical Analysis. A Guide to Best Practice” (Wiley-VCH, 2005, 2015, 2024).