Overview
Stability studies are a vital yet often underappreciated aspect of product development and quality assurance. This eBook serves as a guide to understanding the principles, processes, and applications of stability testing across various industries, with a particular focus on pharmaceuticals, medical devices, and food and beverage products. From regulatory frameworks to experimental design and data interpretation, you'll gain the tools needed to confidently navigate the intricacies of stability studies and ensure your products remain safe, effective, and reliable throughout their intended shelf life.
What is a Stability Study
Stability studies, sometimes called degradation studies, prevent us from consuming products that could be harmful to us. In the pharmaceutical world they ensure that your medications remain effective and safe. They make sure your medical devices continue working as long as they need to. And in the food and beverage industry, there is an expiration date that maintains the nutritional value, taste, and safety of what you eat and drink. In all cases, you use stability studies to calculate a shelf life that ensures that you have statistically backed expiration dates.
Where do the methods behind a stability study originate? In the pharmaceutical industry, the International Council for Harmonisation (ICH) criteria are widely adopted by most countries to determine the expiration dates of medications. Although these guidelines are primarily designed for pharmaceuticals, they are also frequently utilized by other industries, including medical devices and food and beverage, to ensure product stability.
The ICH guidelines include different types of studies including long-term, intermediate, accelerated, stress tests, and photostability.
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