VAL MANUAL- 034 Demonstration and Calculation of Equivalence Criteria of Impurities for API Process Validation

Reference data should be examined to determine if a normal (Gaussian) pattern is evident. If there are sufficient reference batches and examination of the data reveals a normal distribution, a “mean +/-3 standard deviations” (+3 SD) statistical acceptance

VAL MANUAL- 034 Demonstration and Calculation of Equivalence Criteria of Impurities for API Process Validation.doc

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