Tag: Sterility testing in sterile dosage form

Aspects of sterility testing in sterile dosage form

“Sterility testing methods are required to be accurate and reproducible, in accordance with 211.194 and 211.165. USP “Sterility Tests” is the principal source used for sterility testing methods, including information on test procedures and media “Also see clean room classification We will discuss following points in details A. Microbiological Laboratory ControlsB. Sampling and IncubationC. Investigation […]

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