Tag: ICH Q1A(R2)

Apply Risk-Based Strategies to Minimize Stability Testing Commitments

Posted on By

Understanding the Tip: What risk-based stability planning means: Risk-based approaches evaluate the criticality of stability testing based on formulation characteristics, manufacturing history, and existing data. This strategy allows companies to reduce repetitive or redundant testing without compromising product safety or compliance. It involves tailoring testing frequency, sample size, or study duration based on scientifically justified…

Read More “Apply Risk-Based Strategies to Minimize Stability Testing Commitments” »

Stability Study Tips

Follow ICH-Compliant Sampling Intervals for Accurate Stability Assessment

Posted on By

Understanding the Tip: Why structured sampling intervals matter: Stability testing isn’t just about storing products—it’s about analyzing them at critical intervals to track changes over time. Structured sampling intervals are essential to detect degradation trends and determine shelf life accurately. Missing key time points can lead to incomplete datasets, failed regulatory audits, or inaccurate product…

Read More “Follow ICH-Compliant Sampling Intervals for Accurate Stability Assessment” »

Stability Study Tips

Use Early Stress Testing to Reveal Degradation Pathways in Drug Products

Posted on By

Understanding the Tip: What stress testing reveals: Stress testing, also known as forced degradation, involves exposing the drug substance or product to extreme conditions such as heat, light, oxidation, and acidic or basic environments. This approach intentionally accelerates degradation to uncover potential chemical instability. Understanding how and when a compound breaks down helps formulation teams…

Read More “Use Early Stress Testing to Reveal Degradation Pathways in Drug Products” »

Stability Study Tips

Start Stability Protocol Design with ICH Q1A(R2) Guidance

Posted on By

Understanding the Tip: Why protocol design matters: Stability protocols serve as the blueprint for determining a pharmaceutical product’s shelf life. They ensure that the product maintains its quality, safety, and efficacy under specific storage conditions over time. Designing this protocol without foundational regulatory guidance often results in inconsistent data, regulatory delays, or failed submissions. Therefore,…

Read More “Start Stability Protocol Design with ICH Q1A(R2) Guidance” »

Stability Study Tips