Search Results for: Quality Fraud!

One cannot avoid being part of it. It is the regulatory agencies’ (e.g., FDA) and pharmacopeias’ (such as USP) practices and requirements to use the non-validated/non-qualified (hence non-GMP) testers and tests causing the fraud. Any claim concerning the quality of the products, in particular tablets and capsules for brand-name and generic products, must be false.

Blaming and punishing the industry for product quality and manufacturing are not relevant or valid and would not help. Instead, the authorities and pharmacopeias need education, advice, and help in defining quality and setting its standards and specifications (1, 2).

I will be happy to explain the issues with quality assessments in detail and can provide solutions to address them (link).

Regulatory authorities, including pharmacopeias, stated and promoted mandate is to ascertain that consumers and patients receive safe, efficacious, and quality pharmaceutical products such as tablets and capsules. It is important to note that at the commercial manufacturing stage, the safety and efficacy of the products are not usually monitored, only the quality which acts as a surrogate for the safety and efficacy. Therefore, authorities can only claim that they are establishing or monitoring the products’ quality; by extension, products would be considered safe and efficacious. From the industry perspective (both brand-name and generic), it is, in fact, a relatively simple and standard exercise of manufacturing fine chemicals and their composites. They follow the same or similar scientific/manufacturing principles and practices as for manufacturing of any other chemical or its products.

Considering the strong hold of the authorities, manufacturers and distributors can only sell or import/export products that would meet the regulatory/pharmacopeial requirements and/or standards, i.e., they have to comply. In this regard, it should be critical to note that “quality of the products” or “product quality” is an undefined term or parameter, thus, cannot be determined or established. Therefore, claims made by the authorities and/or pharmacopeias for establishing quality are not correct or truthful.

The main reason for this false claim or practice is that the authorities consider and promote compliance as quality, which is incorrect. At present, compliance is not linked to the quality of the products (as it is undefined). However, it is linked to numerous self-created arbitrary, flashy, and catchy phrases (considered as requirements/standards/practices) such as Data Integrity (DI), risk based-assessments, Real World Evidence (RWE), Quality by Design (QbD), Process Analytical Technologies (PAT), regulatory perspectives, precision medicines, patient-centric and many others. However, the fact remains that none of these requirements and practices has any link to the quality of the products (logically or scientifically) as “quality” is an undefined parameter – but confusing and frustrating vocabulary and mumbo-jumbo for regulatory purposes.

This arbitrariness of standards and requirements has choked manufacturing and severely limited access to high-quality products for patients at affordable prices. One of the main reasons for this manifestation is the implementation of arbitrary standards/requirements through facility inspections by “experts” internal or external to the authorities through so-called GMP practices and/or the implementation of other guidelines. Many of these “experts” may, in reality, be characterized as “snake oil salesmen or women” applying “laws” by choosing or picking some “exploitable,” mostly superficial deficiencies (“observations”) to bad mouth the industry and its staff. But, on the other hand, the industry watches this absurdity and humiliation with horror. It does not have any option of being heard that what is required from them is neither relevant nor scientific. The industry has no choice but to bow down to survive – hence the fraud continues with a vengeance and “gained admiration/credibility” of the “experts.”

In short, the public can’t have quality drug products until authorities start setting logical and science-based standards and specifications. As a start, the “quality” of products needs to be defined clearly with a measurable parameter using valid scientific principles. The irony is that if relevant science and its principles are to be followed, these issues can easily be addressed. This would not only result in reducing the regulatory burden but also provide freedom to the industry for manufacturing quality products and open the doors for innovations for affordability and accessibility. I describe such concerns and potential solutions extensively through my blog (link). I would be happy to explain these in person (mailto:principal@pharmacomechanics.com) as well if it helps.

Some suggested blog articles:
(1) Promoting quality standards for drug products: Scientifically speaking, please be systematic and logical! (link)
(2) Possible interpretation of the FDA response to my Citizen Petition – a positive and encouraging development (link).
(3) Pharmaceutical product manufacturing as per current regulatory requirements! (link).
(4) Consumers and patients must wait, and suffer, for the availability of quality pharmaceutical products such as tablet/capsule as well as their genuine and affordable prices. The reason may surprise you! (link).
(5) Comparing Quality Standards – Pharmaceutical vs Consumer Products (link).

The stated and promoted mandate of regulatory authorities, including pharmacopeias, is to ascertain that consumers and patients receive safe, efficacious, quality pharmaceutical products such as tablets and capsules. It is important to note that at the commercial manufacturing stage, the safety and efficacy of the products are not usually monitored, only the quality which acts as a surrogate for the safety and efficacy. Therefore, authorities can only claim that they are establishing or monitoring the quality of the products, and by extension products would be considered safe and efficacious. From the industry perspective (both brand-name and generic), it is, in fact, a relatively simple and standard exercise of manufacturing fine chemicals and their composites. This follows the same or similar scientific/manufacturing principles and practices for manufacturing any other chemical or its products.

Considering the strong hold of the authorities, manufacturers and distributors can only sell or import/export products that would meet the regulatory/pharmacopeial requirements and/or standards, i.e., they have to be in compliance. In this regard, it should be important and critical to note that “quality of the products” or “product quality” is an undefined term or parameter, and thus cannot be determined or established. Therefore, claims made by the authorities and/or pharmacopeias for establishing quality are not correct or truthful.

The main reason for this false claim or practice is that the authorities consider and promote compliance as quality, which is incorrect. At present, compliance is not linked to the quality of the products (as it is undefined) but to numerous self-created arbitrary, flashy, and catchy phrases (considered as requirements/standards/practices). They are data Integrity (DI), risk based-assessments, Real World Evidence (RWE), Quality by Design (QbD), Process Analytical Technologies (PAT), regulatory perspectives, precision medicines, patient-centric, and many others. However, the fact remains that none of these requirements and practices has any link to the quality of the products (logically or scientifically) as “quality” is an undefined parameter – but confusing and frustrating vocabulary and mumbo-jumbo for regulatory purposes.

This arbitrariness in setting standards and requirements has choked manufacturing and severely restricted access to actual quality products for patients at affordable prices. One of the main reasons for this manifestation is the implementation of arbitrary standards/requirements through facility inspections by “experts” internal or external to the authorities through so-called GMP practices and/or the implementation of other guidelines. Many of these “experts” may, in reality, be characterized as “snake oil salesmen or women” applying “laws” by choosing or picking some “exploitable,” mostly superficial deficiencies (“observations”), to bad mouth the industry and its staff. On the other hand, the industry and the staff watch and bear this absurdity and humiliation with horror without any options of being heard or reacting. The industry has no choice but to bow down to survive – hence the fraud continues with a vengeance and “gained admiration/credibility” of the “experts.”

In short, it is not possible for public to have quality drug products until authorities start setting logical and science-based standards and specifications. As a start, the “quality” of products needs to be defined clearly with a measurable parameter using valid scientific principles. The irony is that if relevant science and its principles are to be followed, these issues can easily be addressed. This not only would result in reducing the regulatory burden but also provide freedom to the industry for manufacturing quality products as well as open the doors for innovations for affordability and accessibility. I describe such concerns and potential solutions in extensive details through my blog (link) and would be happy to explain these in person as well if it helps. Some suggested blog articles:
(1) Promoting quality standards for drug products: Scientifically speaking, please be systematic and logical! (link)
(2) Possible interpretation of the FDA response to my Citizen Petition – a positive and encouraging development (link).
(3) Pharmaceutical product manufacturing as per current regulatory requirements! (link).
(4) Consumers and patients must wait, and suffer, for the availability of quality pharmaceutical products such as tablet/capsule as well as their genuine and affordable prices. The reason may surprise you! (link).
(5) Comparing Quality Standards – Pharmaceutical vs Consumer Products (link).

These are often visitors to manufacturing facilities under the titles of investigators, inspectors, auditors, consultants, experts, compliance officers, etc. (internal or external to the regulatory agencies). Logically and scientifically speaking, they provide no useful or valuable purpose for developing, manufacturing, and assessing pharmaceutical products such as tablets and capsules. They cause hindrances, interruptions, and exuberant costs to industry and by extension to consumers/patients. Their observations and conclusions are based on subjective and narrative discussion, not scientific, measurable, or quantifiable assessments. Their reports are often filled with fancy catch phrases or acronyms such as cGMP, validations, CSV, data integrity (DI), record-trailing, inappropriate SOPs, improper documentation, root cause analysis, and CAPA. These phrases are, in general, book/record keeping (admin/clerical) exercises mostly unrelated to the quality of the products and/or the manufacturing quality. Note that any deficiency or observation, unsupported with corresponding direct and/or validated evidence of the quality of products or their manufacturing (which often is the case), must be rejected as superficial or irrelevant. The industry should protect its employees’ expertise, academic credentials, and manufacturing competence from these “visitors,” who often lack the needed expertise. Seek help protecting your expertise and manufacturing quality products with scientific evidence, knowledge, and support. The following links to articles describing the basis of irrelevancy of often reported deficiencies.

(1) Biggest violators of GMP (link)

(2) Can Regulatory And Pharmacopeial Compliance Practices Establish Quality? (link)

(3) Consumers and patients must wait and suffer for the availability of quality pharmaceutical products such as tablets/capsules and their genuine and affordable prices. The reason may surprise you! (link)

(4) Making unsubstantiated and/or false claims by the regulatory authorities, including FDA, regarding the quality of pharmaceutical products (link)

 (5) Pharmaceutical product manufacturing as per current regulatory requirements! (link)

(6) Promoting quality standards for drug products: Scientifically speaking, please be systematic and logical! (link)

 (7) Quality assessment of pharmaceutical products – regulatory/pharmacopeial standards and methods require urgent attention! (link)

 (8) Regulatory/pharmacopeial assessments of the quality of the pharmaceutical products – in the grip of falsehood and fraud! (link)

 (9) Time to rescind the regulatory requirements of bioequivalence evaluations and the current pharmacopeial drug dissolution practices as these do not provide quality assessment of pharmaceutical products (link)

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

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

I believe my postings are not offensive, nor am I a crackhead with subnormal intelligence to get such impolite responses. However, it is because my postings do not fit with the current practices, challenges, and strongly held dogma (in the name of science). I consider this is normal whenever the status quo is questioned, which my posts are about.

My main concern and view is that the assessment of the quality of products and the claims made, including by regulatory authorities and pharmacopeias, 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 the quality of the products has never been defined in measurable terms, 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, management and/or specifications comply with the guidance and/or SOPs, then products obtained from such facilities would be of quality. However, 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 currently missing. 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 a waste of time and resources, i.e., one cannot establish the actual quality of the products.

Compliance people who are accustomed to following compliance specifications believe that everything is fine if one meets the specifications. However, they do not realize that the specifications or SOPs they monitor so religiously are, in fact, baseless and, in most cases, foolish. They get offended and feel insulted when this flaw is pointed out to them. The reason is that they have been trained (“brain-washed”) to listen and believe in self-promotion and rightfulness. Anything else has to be considered illogical and must be rejected. Instead of listening to the concern carefully, understanding the problem, or studying the underlying scientific issues, they blame and start “shooting the messenger.” They are not hurting me but themselves by exposing their ignorance and incompetency of the subject.

The question is why non-science-based and irrelevant specifications and SOPs are there to start with, and 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, guidance, and advisory practices. What is so difficult to understand about this lack of thinking or competency here? This violates the 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, and observations after observations, with claims that these are based on up-to-date/currently available scientific thinking and knowledge (the result of self-promotion).

The fact remains that all the current guidance document, advice, etc., at present, at least for tablet/capsule products, has no link to the quality assessment of the products – because it is undefined. Therefore, all the suggested guidances, SOP, and specifications, and their implementations, at the drug application reviewing and facilities inspection stages are scientifically irrelevant and useless.

In addition, the practice opens the door for new specifications and irrelevant requirements because nothing is required or needed to show relevance. Everything becomes good, necessary, and admirable. The more convoluted and complex it is, the better it will be. No questioning and challenging is allowed but wholehearted acceptance and following.

Any unusual thought has to be rejected as crazy and jargon. This lack of product quality definition and development of an arbitrary guidance-based system has wrecked the whole system. So much so that non-validated / non-qualified testers are forced to be used. A cardinal sin if the industry would follow such a practice). If the industry or any other organization had conducted such a practice, it would have been banned from doing business, leading to bankruptcy and persecution of its keep players. Theranos is one current example of going through this process.

On the other hand, the same regulatory authorities, which punish others for such a crime, actively encourage the industry to sell non-validated testers and methods and seek advice and suggestions for developing guidance documents for the industry to follow.

 I hope people will understand my view and reason for my writings, i.e., bringing science for the product evaluation. A critical first step in this regard will be defining the quality of the products with measurable parameters and THEN setting the corresponding specifications for compliance.

n the end, I request that you 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 from understanding the issue and addressing the deficiencies.

This causes me to write and respond at every opportunity to keep highlighting the problems. So 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 @ https://bioanalyticx.com/.