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]

Bob:

I hear and feel your frustration. What you have described is reality and quite a common one. Why is it so? The reason (Charles mentioned it somewhere as well) is that authorities make claims of being science-based when they should be considered as regulatory authorities USING science and its principles. Let me explain that they (authorities, including pharmacopeias) 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 that everyone must 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, even a very basic one. In fact, practically, they can never have the necessary resources and expertise – but they make the related laws and enforce them. The law requires setting standards/specifications; however, some (for their own gain) have twisted it to provide guidelines/advice on how the industry should behave and be working. They are guiding the industry on how to develop and validate methods, which methods to use, and what approach to take (management, record keeping (“data Integrity”), QbD, PAT, statistical methods and modeling, 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 addressing the issue is to have more guidelines and/or pass the blame to the industry and, if possible, punish it, sometimes fairly harshly. Unfortunately, most likely the country (or countries) will lose national/local industry and the underlying science, if they have not already, to developing countries that are fairly ahead in the “game.”

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

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

Best.

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