Rework:
Rework mean Subjecting
an intermediate or API that does not conform to standards or specifications to one
or more processing steps that are different from the established manufacturing
process to obtain acceptable quality intermediate or API (e.g., recrystallizing
with a different solvent).
Reprocess:
Reprocess
mean 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.
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