By Gawayne Mahboubian-Jones, Program Manager, Excellence in Science and Design, Philip Morris International
Editor’s Note: The following was originally posted on LinkedIn.com 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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