Microbiology FDA 483 (Dr. Reddy’s Laboratories): The accuracy, sensitivity, specificity and reproducibility of test methods have not been established
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Dr. Reddy's Laboratories Ltd.
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Specifically, accuracy, sensitivity, specificity, and reproducibility of TAMC (Toral Aerobic Microbial Count) test used to routinely test *** for the presence of microorganisms has not been established.
*** samples are collected as per environmental monitoring SOP-GLOB-QC-OI 10-5.0 and tested for Total Microbial Counts present in the *** Test method STP # MOA-100001931-03, *** USP”. The QC Head stated the firm has not performed any method validation, method verification, and/or method suitability studies if the method is suitable for intended use.
Additional deficiencies were observed in the Test Method STP # MOA- 100001931-03, *** USP”. As per this method sample for TAMC test is prepared by *** Specification document # ROA-100001931-02 sets the specifications of *** CFU/mL for Total Aerobic Microbial Count (TAMC) test for *** analysis. The corresponding specifications for *** mL of samples are *** CFUs. The site has not challenged this test to observe and count *** CFUs on the *** mm filter. The site QA Head acknowledged that it is not possible to count *** colonies on *** mm size filter.
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FDA 483 relevant to Microbiology
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