Type II variation [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-06-22 15:12 (1507 d 12:40 ago) – Posting: # 18948
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Hi Beholder,

» […] whether we need to perform BEQ study in case of changes in amount of tablets in production batch or not? I refer to the table B.II.b.4 Change in the batch size (including batch size ranges) of the finished product

Yes because that’s a Type II (i.e., a major) variation. Only if the conditions for a bio­waiver are applicable you could get around an in vivo study.

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