Regulatory Inspections Focused on Intermediate Stability Data
Regulatory Inspections Focused on Intermediate Stability Data Regulatory Inspections Focused on Intermediate Stability Data: Preparing for Global Audit Success Intermediate stability studies, typically conducted at 30°C ± 2°C / 65% RH ± 5%, are not just backup data—they’re critical datasets often scrutinized during regulatory inspections. Agencies like the FDA, EMA, and WHO PQ examine intermediate…
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