People try to understand the logic and scientific principles behind the (pharmacopeial and regulatory) “compliance” requirements for meeting the quality aspect of the pharmaceutical products such as tablet/capsule. However, there is hardly any scientific principle involved in most of the current “compliance” requirements in the area. Most compliance requirements are based on subjective (individual or collective) opinions and guesses, often presented through publications or regulatory guidance documents to gain or establish their authenticity. For example, in the area of establishing quality of the manufactured products, such as tablet/capsule of both generic and branded products, nowhere it is defined what would be considered as a “quality product” and how the quality should be measured or established. However, all the pharmacopeial and regulatory requirements (national or international) make claims of achieving it. Is it not interesting that quality of a product is not defined or known, but claimed to be achieved, how?
