Why are regulatory authorities, including pharmacopoeias, allowing and promoting (through guidance documents and seminars/conferences) the use and sale of non-GMP compliant drug dissolution testers?

This is clearly a violation of commonly accepted manufacturing practices (such as US FDA – GMP/GLP requirements) which dictates that tests and testers employed must be validated and qualified for their intended use. The use of non-GMP compliant apparatuses provide incorrect or false (quality) assessment of pharmaceutical products in particular tablet and capsule – for both innovator and generic products. Will it not be correct to say that public and the manufacturers are receiving false information and assurance about the product quality?

Why are the pharmacopeias, in particular USP, not seeking and/or accepting new ideas and scientific research for addressing the issue – noting that no one at present is determining, or can determine, drug dissolution characteristics of any product using pharmacopeial dissolution testers?

Please share your thoughts and discuss approaches to address the situation so that development and manufacturing pharmaceutical products (such as tablet/capsule) could become simpler and efficient.

Some relevant links for further details:

(1)    http://www.drug-dissolution-testing.com/?p=2907

(2)    http://www.drug-dissolution-testing.com/?p=3214

(3)    http://www.drug-dissolution-testing.com/?p=3007

(4)    http://www.drug-dissolution-testing.com/?p=3217

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