Representative batches? [Regulatives / Guidelines]

posted by Dr_Dan  – 2010-08-05 08:58 (4097 d 01:29 ago) – Posting: # 5724
Views: 13,988

Dear ElMaestro, dear Helmut and all who contribute to this fruitful discussion

» I changed the category; doesn’t look as a statistical issue to me (any more).

You are right Helmut, I made the same experience, at the beginning it looks like a statistical problem but in the course of discussion it turned out that it becomes more and more a regulatory issue. But can you argue with the assessor without statistics?

As other sponsors we selected T & R batches which matched closely. Comparative dissolution profiles showed similarity and the assay content differed less than 5%.
From the quality point of view we see no difference between the batches.

The logic consequence would be that for the release of any batch you produce for the market you have to perform a BE study as quality control.

I am still at a loss.

Kind regards

Dan

Kind regards and have a nice day
Dr_Dan

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