Analytical Method Validation | Avoiding Common Pitfalls in CTD Submissions
As a Stability Assessor at the Egyptian Drug Authority, I frequently review CTD files, and I’ve noticed recurring mistakes in the Analytical Method Validation section. These oversights not only delay regulatory approvals but also question the reliability of the data presented.
Here are some common pitfalls to avoid:
1. Incomplete Validation Reports: Failing to address all required parameters (e.g., accuracy, precision, robustness, linearity) per ICH guidelines.
2. Inadequate Specificity Testing: Overlooking the impact of impurities, degradation products, or matrix effects.
3. Inconsistent System Suitability Criteria: Lack of alignment between validation and routine analysis phases.
4. Neglected Method Transfer: Missing or poorly documented method transfer between labs.
5. Insufficient Stability-Indicating Power: Methods that fail to detect critical degradation pathways.
Addressing these issues not only ensures regulatory compliance but also strengthens the credibility of your submission. Let’s strive for accuracy and quality in our work to uphold patient safety and industry standards.
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