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Arrogance, Ignorance, and Fear: Too Much for QbD to Overcome?

    Arrogance, Ignorance, and Fear: Too Much for QbD to Overcome?

    By Gawayne Mahboubian-Jones, Program Manager, Excellence in Science and Design, Philip Morris International

    Editor’s Note: The following was originally posted on and is republished with permission of the author.

    There are several problems compounding the difficulty of moving forwards with Quality by Design:

    1. We have an industry which currently does not understand many of its basic process sufficiently to be able to control them in-line.

    2. We have an industry which has little or no incentive (commercially or from the regulators) to develop sophisticated understanding of its processes.

    3. We have an industry which is convinced of its own uniqueness . . . that is, that it has to learn all the lessons by itself, and that no learning from other industries is applicable to it.

    4. We have an industry which has created a mindset amongst its key workers that what is currently practiced is ‘state-of-the art’ and is rigorously based in science.

    5. We have an industry which is completely unable and/or unwilling to recognize its own weaknesses in the manufacturing forum. This may be simple arrogance, it may be fear of the regulators, or it may be ignorance. Personally, I think it is a mixture of the three.

    These are generalizations and I accept the weakness in making them. However, they do cause us to ask a simple direct question: If all or most of the above apply to most pharma companies, then what is the best (i.e., fastest and most effective) method of bringing about change?

    I have no doubt that the change will come, but if we allow it to overtake us like an unseen, unexpected catastrophe then the industry will suffer massive damage , and as a result so will the consumer. Surely as individuals who see what needs to happen, we have to seek to act to bring about that change in a planned way so that at least the consumer does not suffer more than the minimum absolutely necessary.

    So back to the question: what is the best way of bringing about change in such an environment?

    I would welcome thoughts from all others, but my personal view is that we have to make it commercially painful for the pharma companies not to move forwards. We can do that two ways, through strengthening regulation or through increased competition. The trouble with the first is that it makes the industry increasingly dependent on the regulators. The only way we get pharmaceutical manufacturers who deliver quality because that is what is required, is to make quality a key issue in the marketplace for the products.

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    5 Responses to “Arrogance, Ignorance, and Fear: Too Much for QbD to Overcome?”

    1. Phil says:

      I disagree that making it painful for Pharma will solve anything; the real issue is this – Pharma justs wants to get the new product approved for marketing with zero hiccups because they do not want to afford otherwise. Therefore, Pharma will take the path of least resistance – and the resistance will always come from the FDA; therefore, I believe it is the FDA that must change. This change must come in the form of an upheaval in the mindset of regulators and could include:
      1) staff that are truly competent in understanding the science AND the manufacturing technology; current average expertise is still waddled in the past with as about as much understanding of PAT and what it takes to accomplish QbD as Pharma itself is willing to put into it
      2) FDA product reviewers who stop knee-jerk requirements for product specifications, testing and unfounded GMP (example: testing for endotoxin on topical products simply because the product is protein derived)- the FDa talks about using Risk Analysis but rarley seems to understand that they too must participate

    2. paulthomas says:


      Gawayne obviously points the finger at industry because there are limits to what further regulation can do. Certainly, FDA needs to change its mindset, and I think those within the Agency would say that it’s a gradual process, but one that is slowly and inevitably happening.

      Yesterday’s post from Ali Afnan (formerly of FDA) is also very critical of industry. (Link: As he says: “But who must take the lead on all this? Hint: It’s not the FDA.” Both Ali and Gawayne seem to be saying that the industry needs to look beyond the compliance and regulatory aspect of QbD and really take a hard look at the financial and operational benefits, which will resonate much more with C-level people.

      Paul Thomas

    3. Phil says:

      Paul, thanks for the reply; let me respond to one thing: I understand the position that FDA believes if industry just “got on board” with QbD because it is the right thing to do, if not only just from a bottom-line business perspective, that this issue would dissolve away into a better global pharmacuetical production environment, but the problem for industry is that real QbD is an expensive undertaking and it is difficult for most reasonably-sized pharma companies to put that kind of money up front for an unproven product….it is simply a case of economics and I think that is what the FDA doesn’t seem to want to help industry with. Everything is cost vs. benefit!

      • paulthomas says:


        Yes, “cost vs. benefit” may become QbD’s mantra here in the near future. Today’s post from Girish Malhotra ( aims to provide some guidance as to how manufacturers can even begin to measure ROI or potential ROI of QbD projects (in this case, he looks at applying QbD to existing rather than new processes).

        And as Gawayne says, hopefully the marketplace will provide the ultimate incentive. If companies who are adopting QbD begin to see, and document, a clear competitive advantage, other manufacturers will have no choice but to follow suit.

        I’m reminded also of what Gerald Migliaccio of Pfizer has argued, that QbD has many unseen and incremental rewards for manufacturers (large and small) the more it is implemented: “Some people have said QbD is expensive, but there’s a very large value proposition here . . . We have found that as you get more mature in QbD, you’re doing a lot less non-value-added work around what is not critical.” Here is my writeup of his talk:


    4. aajax says:

      Has anyone done a good analysis of the cost to the public of drugs quality problems? How many lives were lost or damaged, and what are we willing to pay as a society (because the public pays for this stuff, not so much the drug companies) to prevent future damages? If the rule of thumb is 5 million dollars to save one life, I suspect the industry is already spending multiple millions on quality that could more beneficially be spent elsewhere, perhaps in eliminating health hazards in pharmacis and hospitals. If anyone can, please persuade me otherwise.


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