The purpose of the evaluation of generic products, such as tablets and capsules, is to establish that the two or more products containing the same drug provide the same/similar plasma profiles of the drug -independent of their formulation and manufacturing attributes. Thus, evaluation or testing must be product-independent. If requirements and standards are based on product-specific attributes, then these would not be applicable to other products, including generics, as they could have different attributes (formulation/manufacturing). In addition, product-specific testing and standards are similar in concept to labeling an item’s weight (drug, excipient, etc.) with a weighing-scale associated with it – which obviously would be unacceptable.
The concept of product-independent product evaluation would be scientifically valid and facilitate simpler and expeditious product evaluation and approval.
Therefore, the concept of product-dependent assessment of products requires reconsideration. I hope this suggestion will be given favorable consideration.