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InterviewSolution
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How Many Batches To Be Considered For Process Validation? |
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Answer» The EMA draft GUIDELINE states “a minimum of three consecutive batches”, with JUSTIFICATION to be provided (there are some exceptions to this STATEMENT). The US FDA guidance states that the number of batches must be sufficient to provide STATISTICAL confidence of the process. It is a subtle, but important distinction in the approaches. The EMA draft guideline states “a minimum of three consecutive batches”, with justification to be provided (there are some exceptions to this statement). The US FDA guidance states that the number of batches must be sufficient to provide statistical confidence of the process. It is a subtle, but important distinction in the approaches. |
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