Bracketing Approach

A validation scheme where only batches on the extremes of certain justified design factors are tested during process validation

EMA, Process Validation, defines the bracketing approach as a validation scheme or protocol designed such that only batches on the extremes of certain pre-determined and justified design factors (e.g., strength, batch size, pack size) are tested during process validation. The design assumes that validation of any intermediate levels is represented by the validation of the extremes. Where a range of strength is to be validated, bracketing could be applicable if the strengths are identical or very closely related in composition (e.g. for a tablet range made with different compression weights of a similar basic granulation, or a capsule range made by filling different plug fill weights of the same basic composition into different size capsule shells). Bracketing can be applied to different container sizes or different fills in the same container closure system.]