You have to appreciate the 'guts' of some people to take one statement at a training from a true subject matter expert and twist it to mean they can do whatever the F they want to. I was at a training when a very amazing presenter made the statement about how the agency cannot write up an API manufacturer sighting 21 CFR 210 and 211, that the investigator is beholden to write you up to the FD&C act. That is a true statement. Will be true all day. But you have to understand the weight of the statement. Being written up to the FD&C act I would state is worse. Further, think about this, how are investigators trained regarding cGMP? Yes to 210 and 211. Investigators are trained one way. They have discretion and they are people. They can't write you up sighting 210 or 211, but GMP is GMP. The incorrect takeaway from key people was that: 210/211 was not applicable to API (sort of true) and therefore those GMP requirements had no bearing (not true). Reductivism at its finest. I still shake my head. This was willful. And they did not listen to the quality professional telling them otherwise. Full stop. Maybe this should be a cautionary tale for subject matter experts but F that, this was willfully taken the wrong way.
I clarified this with the instructor. I had them clarify with the group. The reductivism was still rampant.
Read for yourself. https://www.fda.gov/media/75201/download
This is not a new era. But please be prepared that the folks that are going to oversimplify what regulation does and does not do are going to be bold and rampant. Combined with there being a tolerance for 'alternative views' these days and Quality Professionals need to be vigilant. During the pandemic, everyone became a virologist or immunologist. In the coming years I expect that every operations person will continue to become a armchair quality and regulatory professional as regulations are scrutinized in an even more openly hostile environment.
I find it amusing that a keyhole reading of a single statement in a guidance or a training is taken as commandment. All when the regulation is clear and more importantly they don't read the full guidance for total context.
Regulation is the bare minimum. It is the lowest bidder that meets the government contract. Regulation is because we have people that walk and breathe and run companies that advocate for the bare minimum. Regulation is there because our industry is fraught with these lowest common denominator people.
Here is the rub, I understand why some people push the boundaries for regulatory. They have a therapy or device that would not be profitable otherwise to make. Healthcare is a right as far as I am concerned. But so is taking a therapy or using a device is as safe as practical with known risk/benefits. That is not a political statement. It is a human one.
There should not be a business or manufacturing choice that introduces new risks batch to batch. The patients need to be fully informed (or capable of being informed) that the product purports to have all the quality characteristics it was approved for use.
However the majority of those who push the boundaries of regulatory requirements are doing it for pushing product out the door with the leanest checks and burdening the people responsible for release with undue pressure under ridiculous timelines.
The quality people care. I have seen the tears in their eyes. The burnout on their bones. I have existed in these companies to push to normalcy. To push back on schedules and make a system. To resource appropriately. To prioritize upstream and reduce defects.
I have been and always will be a continuous improvement evangelist.
So then when we extend it to correction and continuous improvement here is what I have to say:
- If you are not good at corporate politics and are the quality leader, I implore you to get in the game. You have a professional responsibility to push improvement. Fix it or get out of the seat. Get a spine and strengthen it.
- Start talking about quality culture and responsibilities. Especially talk about Management Responsibility per ICH Q10.
- Use risk management to cut both ways. For the longest time it was to take liberties (inappropriately). Make management sign off on residual risk. Make the consequences of the risks apparent and make sure they are in the context of patient safety/defects. Be clear in what they are signing in the approval statements.
- Document EVERYTHING
- Continuous improvement is the system level, not the person level. Retraining/instruction/communication is a containment action not a corrective action.
- Elimination of the risk/hazard is the gold standard. We all know how hard that is to come by. Fiercely advocate. If you can't get it the first time, trend and collect data.
- Communicate everything up the chain of command. Talk about defects, risk, trends, and tell them why. Put a cost to the defects/deviations including lost time and schedule impacts. Talk about missed opportunities and what we have known and for how long. Make sure those breadcrumbs are easy to find and documented in communications to management. Make the impacts easily accessible.
- Talk about liability and expectations from regulators. Use warning letters and 483 as your friends.