Please God protect us from the ignorants – the regulatory/pharmacopeial authorities!

They are promoting and imposing fake science, irrelevant and invalid scientific methods, false data/statistical analyses and foolish manufacturing/inspection practices. This is also creating unscrupulous “experts” and “expertise” in the area multiplying damage to the industry as well as consumers and patients due to limited availability of pharmaceutical products and at significantly higher costs.
Stuck and suffocated!

Some relevant links: (1, 2, 3, 4, 5)

Complete disregard of science and statistics!

Some posts about Similarity Factor (F2) which is suggested for assessing quality of pharmaceutical products using drug dissolution testing.

(1)    F2 – Similarity Factor (http://www.drug-dissolution-testing.com/?p=112)

(2)    F2 – Similarity Factor (A Deficiency). (http://www.drug-dissolution-testing.com/?p=1446)

(3)    F2 (similarity factor) or a 2F (faulty facts) factor (http://www.drug-dissolution-testing.com/?p=2038)

(4)    F2 – Similarity Factor (http://www.drug-dissolution-testing.com/?p=2595)

(5)    F2 (similarity factor): An arithmetic skill-test – not a widget for quality assessment of pharmaceuticals. (http://www.drug-dissolution-testing.com/?p=3091)

(6) Similarity Factor (F2) – false and illusionary “statistics”! http://www.drug-dissolution-testing.com/?p=3222

Quality of pharmaceutical products – a quiz!

If one asks a physician and/or pharmacist inquiring whether a product prescribed is of quality; the response would be – sure. But why would it be of quality? The response would be, because it is approved by the regulatory authorities such as FDA, Health Canada and other national agencies as they assess and establish the “quality”.

Now ask the authorities the same question! Their response would be sure – because we use up-to-date knowledge and most elaborate manufacturing facilities assessment approaches for such. But the question is what is that “such”? Would you be able to equate or differentiate quality of two given “blinded products” from different manufacturers or generic vs brand name? Their answer most likely would be – well it is not that simple!

The reason being no one knows what a quality product is! It has never been defined hence cannot be determined and/or established. Period!

I have made some suggestions to address this unfortunate situation – please have a look here (1, 2) , or contact me for details at principal@pharmacomechanics.com.

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

Quality of pharmaceutical products: Lack of scientific expertise and understanding at the authorities, including pharmacopoeia, levels requires attention!

[I posted the following comments on one of the LinkedIn discussions (link); I think visitors of this website would also find it a useful read]

Bob:

I hear and feel your frustration. What you have described is reality, and quite common one. Why is so? The reason being, (Charles mentioned it somewhere as well) that authorities make claims of being science based when in fact they should be considered as regulatory authorities USING science and its principles. Let me explain this that they (authorities including pharmacopoeias) should not be doing science but USING science developed elsewhere only to set and enforce standards/specifications. However, authorities suggest, develop and enforce (through guidelines) analytical methods/procedures which everyone has to follow.

Working within a regulatory agency (Health Canada) for 30 years, and having relatively close interactions with counterparts in the FDA and the USP, I can say that they do not have the resources and expertise to understand or conduct the needed science, not even very basic one. In fact, practically they can never have the needed resources and expertise – but they make the related laws and enforce them. The law requires setting standards/specifications; however, somehow some (for their own gain) have twisted it to provide guidelines/advices as how the industry should behave and be working. They are guiding industry how to develop and validate methods, which methods to use, what approach to take (management, record keeping (“data Integrity”), QbD, PAT, statistical methods and modelling, manufacturing “continuous” vs “batch-wise” etc.). They have dug a big and deep hole for the Agency and the Agency does not know how to get out of it – as they do not have the needed scientific expertise. Their approach to address the issue is to have more guidelines and/or pass the blame to the industry and if possible punish it, sometime fairly harshly. Unfortunately, most likely country (or countries) will lose national/local industry and the underlying science, if have not already, to developing countries which are fairly ahead in the “game”.

To address the problem, in my view, authorities (and pharmacopoeias) have to go back to their main mandate or objective i.e. to become standards setting and enforcing organisations. For example, if they like that public should get quality products (in your case analytical methods) then they must define and provide standards/specifications for such which are missing at present. Therefore, Agency is not fulfilling its given mandate that needs to be addressed.

BTW if you have not noticed, my Citizen Petition (link) is precisely concerning and highlighting these flaws or weaknesses of the science, at the Agency level, in the area of analytical method development. The Agency suggests a number of guidelines for conducting drug dissolution test (which could be considered as one of the simplest analytical tests/techniques). Amazingly the recommended apparatuses have never been validated for their intended use, showing lack of understanding of scientific expertise at the authorities/pharmacopoeias. I am quite optimistic that my Citizen Petition will be accepted which will open the door for addressing the issues/frustrations, you and many other describe. Perhaps you would like to take this route as well to convey your specific issues to the Agency.

Best.

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