Regulatory requirements for establishing quality of pharmaceutical products – serious scientific and cGMP deficiencies and flaws!

[I posted the following comments on a discussion on the AAPS Community Forum; I think visitors of this website would also find it a useful read].

Thanks for your comments in response to my post. I am not sure how should I respond because focus of your comments is more of philosophical than subject matter.
Indeed I worked with Health Canada as a research scientist to provide support and critic on the underlying scientific aspects of the assignments. Most of my laboratory work has been published and views have been known publically as well – as you noted. I have never undermined any ones’, including authorities’, hard work or practices. However, through my laboratory work and related applied experience, I did find some very disturbing misunderstandings about the use of science for quality assessment of the pharmaceutical products. The drug dissolution testing is one part of it and the second more noticeable is the claims of establishing quality of the manufactured products in particular tablet and capsule. These misunderstandings should be highlighted and addressed, in my opinion, not that be ignored and concealed otherwise everyone involved in it will lose their credibility, in particular scientific, for a long time to come.
Your statement that “We, working in the industry, have worked very hard trying to make it work.”, I am sorry what does it mean? Can you determine dissolution characteristics of a given blinded product sample? Have you used a validated dissolution tester for dissolution testing, how? How could you or anyone else develop a valid dissolution method without the availability of a validated dissolution tester? Are you able to define and establish quality of a product using drug dissolution method, how? Please, note that quality of the products is not even defined yet with a measurable parameter, then how could a dissolution test be used as a quality control tool? These are some of the unanswered questions about the use of flawed science and its practice in manufacturing and regulatory assessments. These questions are not directed towards you as a person but to the industry and regulatory authorities in general. I do not know how I can specifically direct my concerns only to the regulatory authorities. I do not think that AAPS Community Forum is only for the industry. I observed it is equally read and participated by the regulatory scientists as well. A discussion was just started on this community forum by a scientist from FDA (e.g. see under METHODS IN IMAGING DATA ANALYSIS).
So please join hands with me and inform the regulatory authorities that there are serious problems in regulatory requirements rather than suggestion of avoiding discussions of these issues. This would not be public service or service to patients but something else!
Regarding the scientific aspect you noted from my post “A dissolution method should not be used for product development until and unless it has been clearly shown …………”, this is not my view or my suggested requirement – this is general principle of science and regulatory (i.e. cGMP) requirement. If anyone is not following or meeting this requirement then the results obtained would not, at least should not, be accepted under (cGMP regulation as an example I quote the following three FDA regulations for your information [21 CFR 111.320, 21 CFR 820.72, 21 CFR 211.194 (a) (2)].Please correct me if I am wrong on this.
In the end, please consider using this forum informing the authorities that fundamental scientific principles, as well as cGMP requirements, are being violated which need to be addressed so that industry could be able to function appropriately and public should receive accurate and honest information about the quality of the manufactured pharmaceutical products.
I will be happy to provide help to anyone in explaining the issues and suggesting possible solutions to such if you suggest or provide leads in this regard. I look forward to future fruitful discussions on the subject with you.

With best regards.

Comments are closed.

Crescent-Shaped Spindle

Now Available
Click here

Archives
Links

PharmacoMechanics