Quality of pharmaceutical products: Lack of scientific expertise and understanding at the authorities, including pharmacopoeia, levels requires attention!

[I posted the following comments on one of the LinkedIn discussions (link); I think visitors of this website would also find it a useful read]


I hear and feel your frustration. What you have described is reality, and quite common one. Why is so? The reason being, (Charles mentioned it somewhere as well) that authorities make claims of being science based when in fact they should be considered as regulatory authorities USING science and its principles. Let me explain this that they (authorities including pharmacopoeias) should not be doing science but USING science developed elsewhere only to set and enforce standards/specifications. However, authorities suggest, develop and enforce (through guidelines) analytical methods/procedures which everyone has to follow.

Working within a regulatory agency (Health Canada) for 30 years, and having relatively close interactions with counterparts in the FDA and the USP, I can say that they do not have the resources and expertise to understand or conduct the needed science, not even very basic one. In fact, practically they can never have the needed resources and expertise – but they make the related laws and enforce them. The law requires setting standards/specifications; however, somehow some (for their own gain) have twisted it to provide guidelines/advices as how the industry should behave and be working. They are guiding industry how to develop and validate methods, which methods to use, what approach to take (management, record keeping (“data Integrity”), QbD, PAT, statistical methods and modelling, manufacturing “continuous” vs “batch-wise” etc.). They have dug a big and deep hole for the Agency and the Agency does not know how to get out of it – as they do not have the needed scientific expertise. Their approach to address the issue is to have more guidelines and/or pass the blame to the industry and if possible punish it, sometime fairly harshly. Unfortunately, most likely country (or countries) will lose national/local industry and the underlying science, if have not already, to developing countries which are fairly ahead in the “game”.

To address the problem, in my view, authorities (and pharmacopoeias) have to go back to their main mandate or objective i.e. to become standards setting and enforcing organisations. For example, if they like that public should get quality products (in your case analytical methods) then they must define and provide standards/specifications for such which are missing at present. Therefore, Agency is not fulfilling its given mandate that needs to be addressed.

BTW if you have not noticed, my Citizen Petition (link) is precisely concerning and highlighting these flaws or weaknesses of the science, at the Agency level, in the area of analytical method development. The Agency suggests a number of guidelines for conducting drug dissolution test (which could be considered as one of the simplest analytical tests/techniques). Amazingly the recommended apparatuses have never been validated for their intended use, showing lack of understanding of scientific expertise at the authorities/pharmacopoeias. I am quite optimistic that my Citizen Petition will be accepted which will open the door for addressing the issues/frustrations, you and many other describe. Perhaps you would like to take this route as well to convey your specific issues to the Agency.


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