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Differences Between Reprocessing and Reworking

Reprocessing involves repeating established manufacturing process steps like crystallization on an intermediate or API that does not meet specifications, while reworking uses a different non-established process and additional testing is required for reworked batches which must be validated if done frequently.

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961 views1 page

Differences Between Reprocessing and Reworking

Reprocessing involves repeating established manufacturing process steps like crystallization on an intermediate or API that does not meet specifications, while reworking uses a different non-established process and additional testing is required for reworked batches which must be validated if done frequently.

Uploaded by

Prince Moni
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
  • Differences between Reprocessing and Reworking

What are differences between Reprocessing and Reworking?

Reprocessing Reworking
The intermediate or API does not conform with The intermediate or API does not conform to
standards or specification which back into the standards or specification which reworked with
process and reprocessing by repeating a different process which does not part of the
crystallization step or other appropriate chemical established manufacturing process.
or physical manipulation steps that are part of the
established manufacturing process
Example: Example:

To achieve the desire particle size resifting the To remove the impurities, different purification
material with previous mesh size. 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.

What are differences between Reprocessing and Reworking? Reprocessing Reworking The intermediate or API does not conform

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