IS THERE ANYWHERE MENTION THAT THE RE PROCESS BATCH REQUIRE
TO KEPT STABILITY STYDY
Answers were Sorted based on User's Feedback
Answer / ankur dwivedi
yes. It is mandatory to keep the re-processed batch for the
stability study as during the re-processing the impurity
levels can be changed and also polymorphic changes may be
possible if using other solvents. Its mentioned in GMP
practices. Nowadays it is one of the criteria from the
Regulatory Department. USFDA person can also ask for the
same. You should go through some good and standard GMP
reference books.
Is This Answer Correct ? | 4 Yes | 0 No |
Answer / satyakumarreddy
As per Sechudle-H every reprocessed batch stability must be conducted
Is This Answer Correct ? | 2 Yes | 0 No |
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