One cannot establish quality of anything without knowing or defining it first. This is simple logic!
Regulatory authorities including pharmacopeias, however, have been trying to prove this logic wrong! That is, they have been making claims of establishing and monitoring quality of pharmaceutical products such as tablet and capsule – without knowing or defining it. Obviously, they will fail and have been failed!
Logically and/or scientifically, none of the products (approved or otherwise) available on the market can be considered of quality. Guidance and compliance-based system, along with the plant inspections, is a thick smoke screen hiding the reality and hindering the progress.
Please, define a quality product and set the standards and specifications accordingly so that appropriate quality products could be manufacture and monitored. For further detail, please see here.
