what are stability studies and its types?
Stability studies provides evidence on how the quality of a drug substance (API) or drug product (Formulation) varies over time.
The impact of environmental factors such as temperature, humidity and light must be evaluated during stability studies.
Types of stability studies:
1. Product development stability :
Photostability testing , excipient compatibility, stress testing and packaging evaluation studies are done through well planned DOE ( Design of experiments) studies during product development stability.
2. Commercial Support Stability:
A company will include a commitment to continue stability evaluation over the commercial life of a product as a part of submission process. During this study generally one batch per year be held at long term storage condition or it may depend on properties of the product.
3. Change Management Stability:
Any change to the components, processing, packaging and labeling of an approved drug product need to ensure that the change has no deleterious effect on the drug product.
For example,a firm may wish to change the API supplier in their drug product. so this change would require stability testing.
