in parentarals (sterile) drugs normally we will collect 20 vials for sterility 3 for BET , 20 for chemical , 10 for additional, for lyo or liquid products based on fill weights.
how we defined that count?
Hi Ramesh, I would assume that the number of samples taken is defined by the number of samples required to perform the testing, including possible retest. So check your QC protocols to verify the number of samples.
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