Author Archive

Testing into compliance – who is doing it and why?

Testing into compliance is a USP/FDA requirement in the area of drug dissolution testing which is the only test available and recommended to indicate quality of the products in particular tablet/capsule.

The reason for the 3- (or 4-) stage testing into compliance (USP/FDA Tolerance) is because of regulatory requirement of using flawed (also non-validated/non-GMP) dissolution testers and methods which are known to provide irrelevant and unpredictable results. Scientifically speaking, there is no reason of using the currently recommended testers, in particular USP Basket/Paddle, for evaluating the products. Blame the USP/FDA for requiring this testing into compliance practice not the analysts and/or the companies.

21st Century Act-ing for Pharmaceuticals Quality – Some Characteristics and Outcomes!

“Quality by International-Culture”, “Designer’s Quality”, “Barrels of Lies”, “Risk/Braggart Analyses”, “Chains of Supply-Lines”, “Quality by Who”, “Quality by Scripts”, “Non-stop Manufacturing”, “Chomping the Provider”, “Bullying the Peasants”, “Pharmaceutically Assumed Technology”, “Curing the Unknown”, “Promoting Deception”, “Spreading Fear”, “Conceit of Acronyms”, “Drumming (fake) Science”, “Observing for Nothing”, “Fun with Data Recording”, “Rotten Desserts with Statistical Toppings” and others (see here and here).

These are not medicines or drugs – unfortunately “experts” and authorities mistakenly consider so!

In reality these are drug products containing medicines or drugs. It is just like candy is not sugar but contains sugar i.e. candy is a sugar product. The quality of drugs or medicines and their products are two completely different and separate characteristics, however, authorities in ignorance and mistakenly describe these as the same. At present, no one, including authorities and pharmacopoeias, can determine or establish quality of such products because “quality” of such is undefined. Therefore, claims most often made following facility GMP-inspections (positive or negative) or regulatory reviews reflecting quality, and by extension safety and efficacy, of the products are simply false. Pay attention to such false claims.

To learn more about the differences in drugs and drug products and how to determine quality of the drug products consider attending the upcoming seminar (link)

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

The stated and promoted mandate of regulatory authorities, including pharmacopeias, is to ascertain that the consumers and patients receive safe, efficacious and quality pharmaceutical products such as tablet and capsule. It is important to note that at the commercial manufacturing stage, safety and efficacy of the products are not usually monitored, only the quality which acts as surrogate for the safety and efficacy. Therefore, authorities can only claim that they are establishing or monitoring 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, which follows the same or similar scientific/manufacturing principles and practices as for manufacturing of any other chemical or its products.

Considering strong hold of the authorities, manufacturers and distributors can only sell or import/export products which 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 as “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 not correct. At present, compliance is not linked to quality of the products (as it is undefined) but 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 setting has choked the manufacturing and severally limit the access to true or 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 implementation of other guidelines. Many of these “experts” may in reality be characterised 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, industry and the staff watch and bear this absurdity and humiliation with horror without any options of being heard or react 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 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, “quality” of products needs to be defined clearly with a measurable parameter using valid scientific principles. 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 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 (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).

Do you know what type and size is your screw? If not, then no point in buying screwdrivers!

Similarly, if you do not know what a “quality product” (screw) is then no point in learning and applying GMP guidelines (screw drivers). You cannot have relevant and useful guidelines as well as quality pharmaceutical products. See here for further details.

Need help in defining quality products as well as in using scientifically sound methodologies for establishing quality, please contact (principal@pharmacomechanics.com).

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