Checklist for Change Control in Stability Protocol Revisions
Start by documenting what exactly is changing and why. This clarity prevents confusion downstream and sets the tone for regulatory justification.
Click to read the full article.
Stability Study Protocols for Different Drug Types
Common Reviewer Questions on Protocol Design
Reviewers often ask whether the selected conditions (e.g., 25°C/60% RH or 30°C/75% RH) reflect the product’s intended market. This requires referencing ICH Q1A (R2) for global zones or WHO guidelines for specific regional deployments.
Click to read the full article.