CRED Managing Variations Effectively

Common deficiencies leading to rejections (3)

 Scientific/specific change codes • Changes are not considered non-significant and therefore do not qualify as a IA variation • FPS deletion of non-significant/obsolete tests

Submission category: Variation to delete thickness and diameter from the FPS; these are not non- significant changes; should be submitted as a Type IB variation.

Submission category: Variation to change the amount of wet granulating water from a specified amount to q.s. Risk assessment, scientific judgement → not non significant change

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