Being in an FDA regulated industry, the question seems odd…a GMP saint or sinner? If we take out the religious context of the query, however, we get to the real meaning of the question. Do we, as individuals and an organization, always work to meet GMP requirements?
When asked this question, everyone typically indicates that, “yes”, they are indeed GMP saints. When I ask them what that means, they usually indicated something along the lines of “being compliant with FDA regulations”.
So, what are you doing to be GMP saints?
My first slide when discussing the Three Sins of GMPs is this one:
Why the pile of burning money?
The answer takes some discussion.
The price of admission into the food, drug, medical device, blood, and biologics industries is a commitment to abide by current Good Manufacturing Practice (cGMP).
Some organizations view this price as a curse – an overbearing government imposing a series of strict regulations that limit growth. While others view this price as a blessing, as leverage in order to rally their employees around a set of standards designed to ensure that their business operates in a state of control.
Those organizations which have chosen the latter view tend to 1) have a better working relationship with the Food and Drug Administration (FDA), and 2) have more successful and profitable businesses.
Sometimes, it’s all in one’s perspective. The burning money represents the loss – of time, of potential, lost opportunities that we have all suffered at either GMP non-compliance or doing things that we thought were good (saintly) but which led to loss. In the end, it does all add up to burnt money – as I say, “At the end of the day, GMPs are all about the work”.
This is the point in where it gets tricky – the work. We all start the day to do a good job. To deliver a product to the end user that is safe, pure and effective. If we are raw material suppliers, a testing firm, a manufacturer or a distribution site; we all want to deliver a product that meets or exceeds the end user expectations. How we get there is key! This is where we can, and often times do, fail.
You see…GMPs mean different things to different groups. To Operations, it can mean generating product in a timely manner, in sufficient quantity, as cost effectively as possible. To Development, it can mean being first to market. To Quality, it can mean masterful performance. As the days and weeks accumulate for the work, we find ourselves working against each other. If you have ever viewed the video of six people in a boat, three facing east and three facing west, each rowing as hard as possible but the boat not going anywhere, you will understand how firms can get out of alignment.
If any one group gets the edge over the others in the boat, say Development gets a motor, then their version of GMP gets the edge. Product is delivered from Development but it may not be completely evaluated as to potential problems in scale-up, sourcing of raw materials, stability, etc. Or Quality could win out and declare absolute compliance is a must – fully testing every unit manufactured. 100% guarantee of compliance with 0% product to sell.
In other words…we become GMP Sinners!
Just the fact that we are in the row boat, rowing against each other, makes us wasteful at a minimum. Perhaps getting close to being sinners?
And before you write me an email that 100% testing each batch with no output is not being a GMP Sinner – perhaps being a GMP Zealot, I would argue that you are sinning. Why 100% test the batch? No confidence in a flawed process?
Is everyone on your team rowing in the same direction?
Where are you in the row boat? Are you all rowing together – to a common goal? Ever feel like you put in effort only to see it have zero results?
Many years ago, I was helping a firm with some production problems. They had received a variety of customer complaints and were working to resolve the issues. When the management called the operators together to discuss some findings and stress that quality was a #1 focus, I decided to follow the workers back to their areas to see what they thought of the discussion. While there, an interesting thing happened. When getting ready to re-start work, the supervisors told everyone that their quota was still the same. Sure…the meeting was great but the quota for output didn’t change and you are required to meet numbers.
I could see the row boat in my mind, workers facing each other, rowing hard – management yelling over the bullhorn “Faster!!”.
How do we avoid becoming a sinner? How do we become a saint?
Great questions. Before I answer, I’ll need to provide a bit of insight into being a sinner with some of the basic sins of GMPs. Join me in the next issue and we will explore what performance makes us sinners.
Thank you for reading my article. If you have any questions, just email me at 3Sins@Compliance-Insight.com