Why I write, what I write, and the way I write – no offence!

It has become a common practice that people get offended with my postings and comments, e.g. on LinkedIn Forums. This leads to receiving pretty offensive responses on the Forums even blocking me from some discussions. On the other hand, hardly I ever receive any such comments or reactions privately but support and admiration of my contributions described in peer-reviewed journal publications, presentations, seminars, direct advices and consultations as well as on my blog postings.

In my view, my postings are not offensive, or I am not a crackhead with subnormal intelligence to get such impolite responses but it is because that my postings do not fit with the current practices, challenges and the strongly held dogma (in the name of science). I consider this is normal whenever status quo is questioned which my posts are about.

My main concern and view is that the assessment of quality of products and the claims made, including by regulatory authorities and pharmacopoeias, are scientifically untruthful and invalid. Without going deeper into technical details (which are described in my publications and/or on the blog), it can be stated that as quality of the products has never been defined in measureable terms, therefore, it cannot be established and claimed. So, all the claims made in this respect are scientifically false and invalid.

People, in particular from the compliance side, believe that if analysts, facilities, operations, managements and/or specifications are in compliance with the guidance and/or SOPs then products obtained from such facilities would be of quality. This is where the problem is i.e. compliance DOES NOT make the products of quality. For a product to be of quality, it must be shown that it is fit for the intended purpose which is missing at present. Hence, the quality cannot be established and monitored.

No matter how many facility inspections are done (with or without “observations/483s”), from quality product manufacturing aspects, the practice is pretty much waste of time and resources i.e. one cannot establish the true or actual quality of the products. Compliance people who are accustomed to following the compliance specifications believe that if one meets the specifications everything is fine. However, they do not realize that specifications or SOPs they monitor so religiously are in fact baseless and in most cases foolish. When this flaw is pointed out to them they get offended and feel insulted. The reason that they have been trained (“brain-washed”) to listen and believe to self- promotion and rightfulness, anything else has to be considered illogical and must be rejected. Instead of listening to the concern carefully and understanding the problem and/or studying the underlying scientific issues they obviously blame and start “shooting the messenger”. They are not hurting me but themselves by exposing their ignorance and incompetency of the subject.

Now the question is why non-science-based and/or irrelevant specifications and SOPs are there to start with, which inspectors are bound to follow? Again, the lack of science-based expertise at the agencies’ level! It goes back to the same deficiency argument that if one does not know a quality product, then how they have been developing specifications, SOPs, and guidance and/or advisory practices. What is so difficult to understand this lack of thinking or competency here? This is serious violation of fundamental principle of science i.e. providing answers or solutions without clearly defining or describing the objective (“quality”) and its measurable parameter. However, without defining the quality of the products agencies keep introducing specifications after specifications, SOPs after SOPs, guidance after guidance, observations after observations, with claims that these are based on up-to-date/currently available scientific thinking and knowledge (result of self-promotion). However, the fact remains that all the current guidance document, advices, etc. at present, at least for tablet/capsule products, has no link to quality assessment of the products – because it is undefined.
All the suggested guidances, SOP and specifications, and their implementations, at the application reviewing and/or facilities inspection stages are scientifically irrelevant and useless. In addition, the practice opens the door for any such new specifications and irrelevant requirements because nothing is required or needed to show relevance. Everything becomes good, needed and admirable, more convoluted and complex it is the better it would be. No questioning and challenging is allowed but whole hearted acceptance and following. Any unusual thought has to be rejected as crazy and jargon.

This lack of quality definition and development of arbitrary guidance based system has in fact wrecked the whole system of science based product evaluation so much so that non-validated/non-qualified testers are enforced to be used (a cardinal sin if industry would follow such a practice). If such a practice would have been conducted by the industry, or any other organization, it would have been banned from doing the business, leading to bankruptcy and persecution of its keep players (Theranos is one current example going through this process). On the other hand, the very same regulatory authorities, which punish others for such a crime, however, actively promoting industry to sell non-validated testers and methods as well as seek advice and suggestions from them for developing guidance documents for the industry to follow.

I hope people will understand my view and reason of my writings i.e. bringing science for the product evaluation. A required first step in this regard will be defining quality of the products with measurable parameters and THEN setting the corresponding specifications for compliance. In the end, I request that please do not make claims that you (or anyone else) are monitoring or helping in monitoring the quality of the pharmaceutical products – you are not! Such a view is often promoted by the “consultants/experts” which not only give legitimacy to irrelevant and non-scientific practices but also deter authorities in understanding the issue and addressing the deficiencies. This causes me to write and provide response at every opportunity I get to keep highlighting the problems. I hope people will see my point from this perspective.

Please consider reading the following blogs for further details:
(1) Regulatory/pharmacopeial assessments of quality of the pharmaceutical products – in the grip of falsehood and fraud! (link)
(2) Please God protect us from the ignorants – the regulatory/pharmacopeial authorities! (link)
(3) Comparing Quality Standards – Pharmaceutical vs Consumer Products (link)
(4) Quality of pharmaceutical products – a quiz! (link)
(5) And more

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