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A system of reworking batches that do not conform to standards or specifications, including the steps taken to ensure that the reprocessed batches will conform to all established standards, specifications, and characteristics.
(ICH Q7) Introducing an intermediate or API, including one that 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) that are part of the established manufacturing process. Continuation of a process step after an in process control test has shown that the step is incomplete is considered to be part of the normal process, and not reprocessing.
Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities
Publication Date: 2004
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