Holy 483!

by TLM

As the last article ended, some questions were presented:

  • How do we avoid becoming a sinner?
  • How do we become a saint?

And as I indicated, I’ll need to provide a bit of insight into being a sinner with some of the sins of GMPs as stated by the FDA.

With insight, let’s explore what performance makes us sinners … and by performance, I mean “WORK”!

How do we get off track?

I don’t think anyone starts their day, their year or their career with the thoughts of “what can I do to really mess up”. Unless you have some real psychopathic tendencies, you do your best to do a good job. You want to help, to be of value and to make a difference. As a supervisor (any level of management or oversight at a shop floor level), you must have some insight into why people don’t do what they are supposed to do.

And there is some science behind these points as they have been gleamed from books and my own observations. Here they are…the baker’s dozen (and by the way…I have a video of me speaking on these points which you can see at our website video site on www.Compliance-Insight.com):

  1. They don’t know or understand why they should do it
  2. They don’t know how
  3. They don’t know what they are supposed to do
  4. They think your way won’t work
  5. They think their way is better
  6. They think something else is more important
  7. No positive consequence for doing it the right way
  8. They think their way is doing it the right way
  9. There is/may be a negative consequence for doing it the right way
  10. Obstacles beyond their control
  11. Their personal limits
  12. There is no way to do it that way
  13. Ingrained habit to do it another way

It’s a different way to think about why people don’t do things…some of us may even think of as second nature…the right way. But I get ahead of myself…

A Little Girl With A Disease

With all things being equal, this little girl would have a great chance at growing up and becoming a successful person. But all things were not equal. Susan has a disease which requires a certain medication to treat…

And the story unfolded. A variety of errors resulted from three root causes or, as I have taught, three sins of GMPs. The “sins” resulted in the shipment of a batch of product that was anything but Safe – Pure – Effective. The batch was sub-potent, contaminated with another drug, some tablets underweight and overweight, mislabeled. If you could think about a potential failure process, it was displayed for all the world to see – especially following the recall and subsequent regulatory actions.

This fictitious scenario was filmed by the US FDA in 1967!! Over 50 years ago, the FDA was discussing things that still exist today. Which brings us to the 3 Sins of GMPs as stated by the FDA!

How do we avoid being a GMP Sinner?

It’s a great question and leads to the topic of “how to become a GMP Saint”. The three sins are powerful when you look at everything that the FDA has cited over the past five decades.

Sinful Habits

Saintly Habits

Sin #1: Poor Planning

Saint #1: Purposeful Planning with Plan-Do-Study-Act approach

Sin #2: Faulty Procedures

Saint #2: Robust and Complete Procedures

Sin #3: Lax Supervision

Saint #3: Supervision that is Masterful, Valuable and Professional


Then why the same 483 observations year after year? Because we don’t even realize that we are sinning against the GMPs.

I can remember learning this lesson very clearly. When working at a firm, a person asked me about auditing and how I knew we were in control. I said that we were auditing, gave some standard answer regarding our control, etc. He then asked, “What are you doing differently now than what you did before the 483 last year?”.

I couldn’t answer it. We had made the corrections. Performed the training. Updated procedures. But the fundamentals of the question yielded that we had not understood why we had not observed the issues before the FDA. What about our people and processes and oversight failed? The concepts of the 3 Sins of GMPs were in my mind at the time but not as well formulated as indicated in this article.

After this question, I had to go back and evaluate our work according to the “3 Sins” and determine if we were moving from “Safe-Pure-Effective” to “Contamination-Mix Ups-Errors”. Holy 483!!!

Wait until you hear the stories of what was found. Of course, that’s in our next edition…

Thank you for reading my article. If you have any questions, just email me at 3Sins@Compliance-Insight.com