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Reprocessing
|
Reworking
|
|
The intermediate or API does
not conform with standards or specification which back into the process and
reprocessing by repeating a crystallization step or other appropriate chemical
or physical manipulation steps that are part of the established manufacturing
process
|
The intermediate or API does
not conform to standards or specification which reworked with different
process which does not part of the established manufacturing process.
|
|
Example:
To achieve the desire
particle size resifting the material with previous mesh size.
|
Example:
To remove the impurities, different
purification solvent used apart from the manufacturing process.
|
The reworked batch subjected for appropriate
testing and stability testing prior to distribution. The quality comparison
should required between original process batch and reworked batch. If required
additional analytical method should be used for reworked batch testing. In case
of reworked to be performed for single batch, then report to be made and batch
shall be released after satisfactory data of stability and finished product quality.
Additionally reworked manufacturing process should validate, in case of
frequently occurrence.
Is it valid if I used water (not a part process) to re-purify intermediates only (not API)? Is it considerable as re-working and reprocessing ???
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ReplyDeleteNo. Any deviation from the established process would be called as Re-work and not reprocess.
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