CRED Managing Variations Effectively

Chapter B – example cont.

Proposal: In addition to the only currently approved pack size (7 and 28 tablets), the proposed new pack sizes 14 and 84 tablets should be submitted as two variations.  B.II.e.5.a.1 (type IA IN ) -> to add pack size of 14 tablets  B.II.e.5.a.2 (type IB) -> to add pack size of 84 tablets These variations should preferably be submitted as a grouping with Annexes reflecting both presentations.

59 Introduction to Classification of CMC (Quality) / Clinical / PhV Variations