Reprocess batch release

Hi Sir,

If any re-process batch is failed to meet specification and after investigation we didn’t find root cause/probable causes.
and while investigation also we don’t have any scientific data and previous trend because this is a new product.
There is no time to take R&D support
we need to release the batch.
How we are going to release the batch?

results are
within range?

After reprocessing the results are meeting

officialy it should be done by trouble shoting and should be released by concern department

Trouble shooting means, whats are the evidences we are going to collect to prove there is no impact on patient safety?

Ideally, how can a failed batch be re-processed without knowing the reason or root cause of its failure??

There has to be some root cause for its failure which can be found out by thorough investigation.
You will have to re-process the failed batch according to your internal SOP.
Finally, “Batch Release / Rejection” whether a regular or re-processed batch is the responsibility of QA.

yes iam agree with you,
here my concern is this is new product only limited technical data and scientific evidences are available. So based on available information, investigation evidences & unit operations monitoring, as QA we will allowed for reprocess. but after reprocess can we dispatch the material to customer without knowing the cause of initial failure?

Yes, based on the limited scientific information available and initial R & D data you can make hypothesis to identify the probable root cause(s) of batch failure as the exact cause of batch failure is not known. On the basis of these aspects the investigation should be closed and QA can release the re-processed batch, if everything is satisfactory. This should be done according to internal SOP.

If the Root cause not identified then QA department refer to R&D to conduct negative experiments to find out the root cause…
After getting conclusion, R&D experiments to be conducted to establish reprocess procedure…Based upon outcome of the yield and quality data, batch to be proceding for reprocess…

Yes, this is “Hypothesis testing” and trying to find out probable root cause tgrough R & D experiments.

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