How to calculate retest date please provide me their reference to guidelines
Retest date API or any Raw materials is calculated from the date of previous analysis. Itβs frequency is generally 6 months to 1 year based on stability characteristics of that API or Raw material at the recommended storage conditions.
You can refer ICH Guidelines on Stability studies of APIs.
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What are the acceptance criteria for BU and CU for process validation batches as per IP