Question: Variability of the API amount in the bottles filled with pharmaceutical suspension is evaluated by analyzing the API content in each of the 20 bottles
Variability of the API amount in the bottles filled with pharmaceutical suspension is evaluated by analyzing the API content in each of the 20 bottles collected in a random sample from each batch and calculating the mean API content and %RSD from the sample data. The release specification for the commercial batches is that %RSD for the sample from that batch must be equal to or less than 6.25 %.
Should we use the same or different testing procedure and the acceptance criteria for that quality attribute during the PPQ Study to be conducted before starting commercial manufacturing of that product? Explain your answer.
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