What type of tests are prohibited for stability studies in manufacturing?

Simulated time methods are prohibited for stability studies in manufacturing because they do not accurately reflect the actual conditions the product will face over time. Stability studies are essential for understanding how a pharmaceutical product maintains its quality, efficacy, and safety throughout its shelf life.

In contrast, long-term studies and real-time tests are both accepted practices in stability testing. Long-term studies evaluate the product under recommended storage conditions over an extended period, which helps determine its shelf life. Real-time tests, similarly, involve observing the product throughout its expected shelf life under its intended storage conditions, providing the most reliable data on stability.

By prohibiting simulated time methods, regulatory bodies ensure that the stability data generated are based on real and predictable changes that the product experiences, thereby safeguarding public health and ensuring the reliability of the pharmaceutical products being manufactured.