Storage & Stability Webinar Series 2024/25
24th September 2024 | 3-4pm CEST
The ICH Q1A guideline provides a framework for stability testing of new drug substances and products to ensure their quality, safety, and efficacy over time. It outlines requirements for testing conditions, storage, and the duration necessary to establish stability profiles.
During the webinar we will discuss:
- Life cycle of drug product
- Testing frequency and storage conditions
- Bracketing/Matrixing (ICHQ1D)
3rd October 2024 | 3-4pm CEST
Construct the design of a storage of a stability study based on the Ishikawa method: medium, material, methods, measurements, machines and manpower.
During the webinar we will discuss:
- Criteria for Storage and Flow
- Ishikiwa diagram
- Adaptability of Analysis
15th October 2024 | 3-4pm CEST
Photostability testing (ICH Q1B) assesses the impact of light exposure on drug substances and products, while transport stress and in-use studies evaluate the effects of shipping conditions and product handling after opening, respectively.
During the webinar we will discuss:
- Photostability ICHQ1B and forced degradation
- Transport Stress
- In-use studies
6th November 2024 | 3-4pm CEST
Discussion on the technical characteristics of storage equipment and conduct temperature/humidity mapping and on-call and maintenance: the keys to success.
During the webinar we will discuss:
- Technical characteristics of storage equipment
- Conduct temperature/humidity mapping
- On-call and maintenance: the keys to success
21st November 2024 | 3-4pm CEST
Forced degradation studies identify potential degradation products and pathways by exposing the drug to extreme conditions, while comparative stability studies evaluate the stability profiles of different formulations or batches. Holding time studies validate the stability of bulk drug substances during manufacturing hold periods.
During the webinar we will discuss:
- Forced degradation
- Holding time
- Choice of formulation
4th December 2024 | 3-4pm CEST
Discussion on the technical characteristics of storage equipment and conduct temperature/humidity mapping and on-call and maintenance: the keys to success.
During the webinar we will discuss:
- Technical characteristics of storage equipment
- Conduct temperature/humidity mapping
- On-call and maintenance: the keys to success
12th December 2024 | 3-4pm CEST
The use of stability data allows extrapolation of shelf life, analysis of off-trend data and definition of specifications (release and shelf life) based on the different stability studies.
During the webinar we will discuss:
- Extrapolation of shelf-life
- Out of Trend (OOT)
- Specifications of product
23rd January 2025 | 3-4pm CEST
ICH Q5C provides guidelines for conducting stability testing on biotechnological and biological products to ensure their quality, safety, and efficacy over their proposed shelf life. It covers testing parameters, storage conditions, and data analysis methods specific to these complex products.