A third example might be the group composed of several products having the same active ingredient and differing only in the concentration of the active ingredient.
In this case, it would be reasonable to select the product having the highest concentration of active since this product would present the greatest cleaning challenge.
As these examples illustrate, the most important aspect of the grouping is the preparation of a logical and scientific rationale justifying the grouping and the selection of the worst case representative.
In certain cases, a clear cut worst case may not emerge. In those instances, it may be appropriate to select two or more “worst cases” to represent the group.
It is unlikely that a single worst case product could apply to an entire line of products having
significantly different formulations and dosage forms.
No comments:
Post a Comment