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 with respect to quality of the products, in particular tablet and capsule for both brand-name and generic products, has to be false.

Blaming and punishing the industry for product quality and manufacturing are not relevant or valid and would not help. Education, advice and help are needed at the authorities and pharmacopeias 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).

FDA response during today’s meeting on …

“Understanding How the Public Perceives and Values Pharmaceutical Quality” link

During today’s presentation ( @ 1:58), responding to a question from the floor concerning the use of drug dissolution methods at the FDA, Dr. Cindy Buhse stated that they use USP methods. Unfortunately, it seems that Dr. Buhse does not realize that USP methods are based on non-validated/non-qualified (hence non-GMP compliant) dissolution testers in particular most commonly recommended ones i.e. paddle and basket apparatuses. Inclusion of a test or tester in the USP does not make it valid or qualified. Validation requires scientific/experimental evidence showing that the testers are good/fit for the intended purpose, which these testers lack.

Scientific studies have clearly shown that these testers do not, and cannot, provide relevant and valid results. It would, therefore, be requested that all the results obtained using these testers should be considered null and void and be removed from products quality evaluations. Furthermore, it should be noted that there is Citizen Petition under consideration at the FDA requesting the withdrawal of these testers, and corresponding tests, from the regulatory use (link).

Beware of GMPiers!

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, at present, they provide absolutely no useful or valuable purpose for the development, manufacturing and assessment of pharmaceutical products such as tablets and capsules but hindrance, delays and exuberant cost to industry and by extension to consumers/patients. Their observations and conclusions are based on subjective and narrative discussion not on any scientific, measurable or quantifiable assessments. Most often, their outcomes are filled with fancy catch phrases or acronyms such as cGMP, validations, CSV, data integrity (DI), record-trailing, inappropriate SOPs, improper documentation, root cause analysis, CAPA, which in general are book/record keeping (admin/clerical) exercises mostly unrelated to quality of the products and/or quality of the manufacturing. Read the rest of this entry

Drug dissolution testing – trend

Often I visit PubMed site (link) to search for recent articles with search phrase “drug dissolution”. On the top right corner of the search outcome a chart appears showing number of articles published on yearly basis for the search phrase. I have reproduced (below) this chart for the years 1970 to 2019. As can be seen from the chart, there is a dramatic decrease in number of publications during the year 2019. This might not be a scientific or statistical conclusion; however, decrease (about 27%) is significant.

There is strong possibility that scientists have lost credibility and relevancy of drug dissolution testing as I have been highlighting for the past number of years in particular through my citizen petition to the FDA in 2018 (link). Going forward, people should take note of this observation and use caution in conducting dissolution tests in particular using USP testers and methods.

Emperor has no clothes

Pharmaceutical products quality – be cautious in making and/or accepting claims in this regard – most of the claims made would be false and baseless at least scientifically. See below and for further details please follow the links (1, 2, 3, 4, 5 and more).

Crescent-Shaped Spindle

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