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c. The “Microbiologic Plate Streaking Validation” dated seven/26/04 is deficient. The validation didn't involve the sample dimensions during which to inoculate Every single plate with concluded product or service. Furthermore, the validation did not involve an evaluation of all out-of-technical specs because of expansion.Evolved gasoline analys

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 Throughout the validation studies for that granulation process, your agency established a temperature number of (b)(4)°C. Your course of action validation review isn't going to give any information to help the method array authorized within the Grasp Batch Information. Your business's response also pointed out you're intending to purchase suppl

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