Tag: shelf life justification

Regulatory Expectations for Accelerated Stability Testing Submissions

Regulatory Expectations for Accelerated Stability Testing Submissions Submitting Accelerated Stability Testing Data: Regulatory Expectations Explained Accelerated stability testing is a vital component of pharmaceutical submissions, especially during early-phase development, technology transfers, and shelf life justifications. Understanding what global regulatory bodies expect in accelerated stability submissions can ensure faster approvals, fewer queries, and greater confidence in…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Bridging Study Strategies Using Accelerated Stability Data

Bridging Study Strategies Using Accelerated Stability Data How to Use Accelerated Stability Data in Bridging Study Strategies Bridging studies are strategic tools in pharmaceutical development and lifecycle management. They help link stability data from one batch or formulation to another, enabling continued product registration or shelf life extension without repeating full stability programs. This guide…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Include Three Primary Batches in Stability Studies for Robust Shelf-Life Support

Understanding the Tip: Why three batches are the standard: Stability studies based on a single batch provide limited insight into variability. Including three primary batches—manufactured at pilot or production scale—ensures that your data reflects consistent performance and accounts for batch-to-batch differences. This approach supports statistical evaluation and strengthens confidence in the proposed shelf life and…

Stability Study Tips

Submit at Least 6 Months of Long-Term Data for New Drug Applications

Understanding the Tip: Why 6 months of data is the baseline: New drug applications (NDAs) require scientific evidence to justify proposed shelf life and storage conditions. At least 6 months of real-time, long-term stability data is the regulatory minimum needed to establish preliminary product behavior over time. This data provides an early trend of degradation,…

Stability Study Tips