Stability testing is an essential step in the product development process, and a mandatory requirement in the life cycle of a treatment.
The International Council on Harmonisation - Quality (ICH Q1A) guidance exists to support companies in maintaining a rigorous approach to stability testing.
In this webinar, we will explore the detail of ICH Q1A and explain how to meet its requirements. We will:
1. Give an overview of stability requirements for different products such as OTC products, generic drug products, consumer health products
2. Explore the guidance for different dosage forms, such as: lozenges; topicals; parenterals; oral solids; and oral liquids
3. Explore current global regulatory requirements on stability testing by USFDA, ICH, EU, ANVISA and APAC
4. Explain the different stability testing approaches for drug products containing multiple APIs with different strength and SKUs
5. Share industry best practice and advise on data evaluation to accelerate stability study timelines
6. Recommend matrix approaches for reduced testing
7. Explore stability protocols and advise on how to set up studies and reporting
8. Advise on temperature cycling, freeze-thaw and shipping studies
Drug companies can ensure the success of their stability testing programme by working closely with partners who have specialist testing capabilities and study management experience. In our webinar, we will explore what to look out for when choosing a partner, from expertise in satisfying international regulatory criteria, to the capability to carry out real-time or accelerated testing to meet your needs.
In addition, a case study from a major stability programme will also be presented during the webinar, offering a real-world example of best-practice stability testing.
Key Learning Objectives
- Understand the different stability requirements for each drug product type
- Learn about the critical stability requirements for your consumer healthcare products
- Understand the key benefits of working with an expert stability study partner
- Understand what needs to be considered to run a major stability programme successfully
