Last year brought news of important research on the state of the Quality by Design movement in the pharmaceutical industry. This previously unpublished report, Understanding Challenges to Quality by Design, was commissioned by one of the world’s leading regulatory agencies, and completed by one of the world’s best known management consultants.
Although it is confidential and considered proprietary, in the end, it was paid for by the U.S. taxpayer and can be accessed, by any U.S. citizen who is patient enough, via the U.S. Freedom of Information Act. In addition, many “bootleg” copies of this report are already circulating out there. Perhaps you have already seen one?
We received one of them some time ago, from a source that has never had any ties to either the regulatory agency or the consulting firm involved, and who has never contributed to our magazine and has no ties with it. I had debated about whether or not to publish it, whether it might do more harm than good to get the information out, and how to frame the information . . . whether to redact or black out some information, for instance.
In the end, the report speaks very eloquently, of progress, of good intentions, of great and noble aims that haven’t yet been achieved, but which are imminently achievable. It dispels some myths about QbD costs and time scales, and also highlights some of the industry’s key, ongoing challenges:
- getting beyond the often costly and short-sighted “first to file” or “time to market at all costs” blind spot
- understanding and using critical quality attributes for continuous improvement
- reducing variability in basic materials such as excipients
But it also speaks of dead ends, of dysfunctional patterns (within and between organizations) that are slowing industry’s progress toward the “Desired State.”
In the end, pharma QbD shows a promise yet to be fulfilled. Since you, collectively, are those who will fulfill it, shouldn’t the buck-passing and finger-pointing stop? It is only the patients taking your products who will benefit from transparency and openness, reduced waste in and greater alignment between the R&D and manufacturing processes.
If you haven’t already seen a bootleg copy of Understanding Challenges to Quality by Design, please read it, discuss it and comment on it, here or at any forum of your choice, including the water cooler.
It’s not a time to take pot shots at the industry, or at FDA. Or to lament what hasn’t happened. That would be too easy, and unfair to those, like you, who devote so much time and energy to improving the status quo. Yet it often seems unreasonable that progress on QbD, and so many smart programs that have been under discussion for nearly a decade, has been so slow.
Informed people tell us that little has actually changed in the industry since the 21st Century GMPs and other groundbreaking initiatives were proposed. You have the power to change that. But only frank and open discussion, and a recognition of human foibles, will get the industry past this impasse, and that discussion needs to involve all functions and all levels within and without pharma (and not just the “thought leaders,” but those in the trenches working within a system and an environment that they didn’t create but which they must live with).
What do you think of the report and its findings? Please share any thoughts you have. In particular, please outline any constructive actions that you think those in the industry (name-brand and generic manufacturers, contract manufacturing and research organizations, regulatory agencies, academia) might take, Kaizen style, to move this critical initiative forward.
–Agnes Shanley, Editor in Chief
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McKinsey report points to different challenges companies and regulatory bodies face. I believe the challenge weight emphasis should be more on the industry rather than the regulatory bodies. Regulatory bodies established the play rules for the companies to ensure product consistency and quality.
Companies will benefit financially from processes that will produce quality product without stop and go sampling and process corrections i.e. QbA. Company management has to ensure that all involved understand the value of first time quality and its financial benefit. Regulatory bodies have to encourage and be the cheerleader of the effort and not the roadblock as suggested/observed in the report.
The industry has reluctantly played by the rules but has never felt the need to spearhead quality efforts from the onset. QbA related costs have never been a concern as they are passed on to the customer. Cost reduction is not a priority. This is due to product pricing methods and lack of competition and attaining margins.
API dosages and annual production volume per site have never encouraged manufacturing technology innovation. Until desire to excel comes from within the companies and shared with regulatory bodies, regulatory bodies will not understand or care about the effort of few.
It is possible that by having a QbD process companies could exceed what the regulations suggest. This could diminish role of regulatory bodies and that could be playing latently in what McKinsey has observed.
Industry has to take the lead for QbD and till that happens nothing will change.
McKinsey mentions COGS reduction of about $20-30 billion. Based on projected 2011 global sales, savings are less than 3% of the total yearly global revenue. If the projected savings are based the current manufacturing technologies and practices then my conjecture is that this is an underestimate of the ongoing savings that could be realized.
If we have command of processes through understanding and the right technology innovation and stop wasting money through QbA methods to produce quality product, the savings could be significantly higher.
I would go out on limb and tout a much higher number of 10% is possible. Such saving will come from yield and cycle time improvement, solvent use reduction, elimination of repeated analysis, improved asset utilization, sustainable processes and other factors. The effort to achieve all this might be marginal to none over the current efforts.
Bottom line:
Report clearly states that we all responsible for progress. Organizations benefiting financially have to lead and everyone else has to facilitate.
Most significant benefit would be regulators and regulated will have NO sleepless nights. ☺ Cheers.