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Are there any criteria that specifies BUD if sterility testing is done?

April 26, 2017bud criteria specifies sterility Testing

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Are there any criteria that specifies BUD if sterility testing is done?

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Sterility storage durations specified at the particular temperature ranges for Low-Risk Level, Medium-Risk Level, and High-Risk Level CSPs may be exceeded when evidence of sterility based on proper testing can be documented. The particular BUD of longer sterility storage times based on testing evidence shall be the judgment of appropriate compounding personnel, and it shall assure chemical and physical stability of the CSPs.