Selecting Primary Batches for Real-Time Stability Testing
Selecting Primary Batches for Real-Time Stability Testing Guidelines for Selecting Primary Batches in Real-Time Stability Testing Accurate selection of primary batches is the cornerstone of a well-structured real-time stability program. Regulatory authorities such as ICH, FDA, EMA, and WHO mandate that stability studies reflect the manufacturing variability of the product, ensuring that the assigned shelf…
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