Difference between reprocess and rework in api

Can you illustrate what is the difference between the reprocess and rework in API

Reprocess means you have to use the same chemicals/solvents as mentioned in the product BPCR.
Generally during reprocessing, API to be soluble in suitable solvent, and give some water washing (acid/base) to the organic layer to remove the impurities followed by recrystallization step.
Reprocess procedure needs to be developed during the product development stage at R&D.
While technology transferring the product to your site, it should contains all the manufacturing process, reprocess procedure and analytical procedures.
Based on product development report you can prepare BPCR and reprocess BPCR.
After reprocessing also product should meet all the specifications without any excuses.

Rework means use the chemicals, which are different from approved manufacturing process.
After rework also product should meet all specifications.

Please refer to ICH Q7 guidelines of GMP requirements of APIs.
Q7 Guideline.pdf (463.7 KB)

This topic was automatically closed 3 days after the last reply. New replies are no longer allowed.