Need for a quantifiable quality parameter for pharmaceutical (tablet/capsule) products

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 tablets/capsules. However, there is hardly any scientific principle involved in most of the area’s current “compliance” requirements. 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 establishing the quality of the manufactured products, such as tablets/capsules of both generic and branded products, nowhere is defined what would be considered a “quality product” and how the quality should be measured or established. However, all the pharmacopeial and regulatory requirements (national or international) claim to achieve it. Is it not interesting that the quality of a product is not defined or known but claimed to be achieved? How?

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