FAQ > Glossary of Terms > R Series > Reprocessing (ICH API Definition)

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Reprocessing (ICH API definition)
Introducing an intermediate or API, including that which does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling, etc.) that are part of the established manufacturing process. Continuation of a chemical reaction after an in-process control test shows the reaction to be incomplete is considered to be part of the normal process, and not reprocessing