Former VP GSK Quality says Good Manufacturing Practice means "great mountains of paperwork"
...and he's not wrong!
Another industry insider
Now we hear from a fellow industry insider, Peter Savin. Peter kindly agreed to be an expert witness in Find It, File It, Flog It, contributing the piece that follows. This goes back to early 2015, before the collapse of the global regulatory system.
Prior to that, regulators said “jump” Pharma said “how high?”. Those days are long forgotten now.
“AN EXPERT WITNESS STATEMENT: PETER SAVIN
Hedley Q: What is your view on the industry’s lead from the regulators?
Peter A: First, many thanks for the opportunity to contribute to your quest and to comment on one of my biggest concerns for the future of our industry, namely the ever-increasing levels of mandate and documentation that we face in our daily operations. I need to say that the industry must grow up. It needs to move away from the child-parent relationship it has allowed to develop with the regulators. Waiting to be told what to do, by regulators and the ensuing consultants, isn’t a good sign of organizational capability or a mature culture.
If you doubt the depth of this child-parent dependence, when you next attend a conference with presentations from both regulatory and industry speakers, just take time to notice how the room fills up when the regulatory speakers are on stage and how everyone is listening intently and studiously taking pages of notes.
Then compare this to the attendance and attention when the industry speakers are on stage.
Hedley Q. I’ve witnessed that for myself many times. What impact do you think this dependence has had on working practices in the industry?
Peter A. Having worked for forty years in the industry, mostly in manufacturing quality and latterly as a consultant, I’ve had the opportunity to see the birth of good manufacturing practice and how it has grown and matured.
Correspondingly, I’ve also seen that the biggest and ever increasing risk that pharmaceutical manufacturing operations face is that of regulatory noncompliance. It saddens me that the public and regulatory perception of our industry and the trust they have in us has plummeted in the past ten years, from being the most ethical industry to being ranked alongside the oil and banking industries.
This decline has been caused largely by increasing regulatory censure and the sheer size of fines being imposed on companies through the US legal system. Something needs to be done to reverse this downward trend in our reputation, and we need to address the compliance issue as a first step.
Hedley Q. What do you think is at the bottom of this trend?
Peter A. The behavior of the industry, as it aspires to continually demonstrate compliance in the dynamic and growing regulatory environment, means that already well-controlled companies often try to show they are better than the regulations and implement more procedures, controls, and monitoring than are necessary.
In addition, the typical response from companies facing regulatory censure is an explosion of self-imposed policies, procedures, and documentation, often advised by some pharmaceutical consultants that strive to prove their value. We fail to understand that the consequence of what we are doing is actually worse than zero payback. The almost exponential increase in documentation has ironically been accompanied by a significant increase in regulatory criticism of companies. There is a clear link between procedural non-compliances and complaints with the increase in documentation. For some reason, there is a commonly held belief that the best response to regulatory censure is to generate more paperwork.
It is sad, but true, that GMP really has come to mean great mountains of paperwork rather than good manufacturing practice. What is also true is that this has not resulted in better-quality products, although in the United States it has enabled huge fines to be extracted from Pharma companies. But that is another topic worthy of open discussion.
So the root causes of the problems lie with both the regulators and the industry itself. Both fail to recognize that this continual drive for ever-increasing complexity is not sustainable, and it certainly isn’t intelligent.
Remember the saying, “Any intelligent fool can make things bigger and more complex. It takes a touch of genius and a lot of courage to move in the opposite direction.”
It is time for the foolishness of unnecessary complexity to stop and courage to be demonstrated throughout the industry.”
That’s it from the horse’s mouth then. A veteran senior pharma quality professional revealing how poor quality is understood in the industry…
…and he’s not wrong!
I am far from sure that the issue is regulation causing the problem. No doubt mountains of paper work, but the simple fact is that pharma fund the regulators, and the regulators are happy to sign off on whatever just to keep the funds flowing. Dont forget, big pharma will love mountainous regulation, whatever they say, because regulation presents a barrier to entry for the smaller players. Given that pharma are the largest lobbyists financially I am sure they get exactly what they want.
As I’ve commented before Hedley I’m familiar with manufacturing practices being involved many years but within a different industry.
It’s not about adding more layers, what is needed is consistent checking, monitoring and samples signed and set aside to make sure qualify control can always check and track whenever there’s been a problem or an issue.
It’s actually funny that you have brought this up, my hubby works for an American company, they are obsessed with paperwork and have increased it massively, at the same time quality control has taken a nose dive and customers complain of the products causing problems on their production lines.
The focus on the importance of the paperwork rather than the product comes from the top down, it seems as if they prefer to be seen as complying rather than actually complying.
Seems we’re at the baffle them with bullshit stage. Look at us and how good we are we’ve added extra layers more than you requested, none of it is worth diddly squat but it looks good on paper.