Type II variation [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-06-22 17:12 (2224 d 10:21 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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