Stability Studies 180 Days or 6 Months for ANDA?
In ANDA submissions, the FDA typically requires stability data for at least 180 days. This data is a part of the chemistry, manufacturing, and controls (CMC) section of the application. The purpose of stability studies is to demonstrate the drug product’s stability over time, ensuring its quality and efficacy throughout its shelf life.
This stability studies typically involve accelerated and long-term testing. Accelerated stability testing is conducted at higher temperatures and humidity levels to simulate the product’s behavior over time. For example, a solid oral tablet might undergo accelerated testing at 40°C and 75% relative humidity for six months.
Long-term stability testing, on the other hand, is performed at standard storage conditions, such as 25°C and 60% relative humidity or 30°C and 65% relative humidity, for an extended period, usually up to two or three years.
The samples from these studies are regularly evaluated for changes in drug content, degradation products, appearance, and physical properties. These assessments are compared to the initial product characteristics to determine the product’s shelf life and establish appropriate storage recommendations for consumers.
By conducting stability studies for solid oral dosage forms in the context of ANDA, pharmaceutical companies can demonstrate that their generic products maintain their quality and effectiveness over time, providing the necessary evidence for regulatory approval.
- Different Types of Stability Studies in Pharmaceutical Industry
- Understanding ANDA Process in the USFDA
Resource Person: Amit Singh
