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jay patel <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Sat, 25 Feb 2023 02:06:54 +0000
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Dear all
 We needed some clarity regarding method validation / method suitability for sterility testing and microbial count testing as per USP <71>, USP <61>, USP <62>.
 We have multiple testing facilities at different locations in the same city. We have demonstrated the suitability of the test method for the product in one laboratory with three independent runs. Now we need to perform the test in another similar laboratory using the same experimental conditions (i.e., same methodology for analysis, same media composition, same incubation conditions, same sample preparation, etc.).
 Is it necessary to verify the method in another laboratory too?
Jaymit Patel
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