Are you in GMP hell??

by TLM

If you’ve never been there, be thankful! I’m not talking about the daily issues – although they can add up – or the week or so of a tough audit. It’s that point where you realize “we have a serious issue”. It can start as a small, almost insignificant item or as catastrophic as a massive 483 or warning letter.

You realize…this is hell! Why the image of the devil shadow? It’s to make a point – that we own the situation. Either by our own actions or inactions – we own it. We could have just started a new job and then realized the mess. It doesn’t matter. We now must fix it. But how?

Before going into the “how” or the “why”, let’s look at some “pictures from hell”. These are either blinded or compiled to protect the identity of the company – many of them from pharma and med device firms around the world. There were so many pictures available… it’s a sad fact that we have so many.

So sit back, have some popcorn and let’s enjoy the views…

Ahh yes! One of my favorites. The lid to a water tank. You are looking at the issues of not passivating the tank for over ten years. Looking further into the system, it was realized that there were various problems. No control – poor planning, lax supervision and faulty procedures.

I guess this is ok??? Does it give you that impression of “we are in control”? It’s hard to see but the probe from this pH meter is in a vial that has “crust” along the top. Would anyone guess lax supervision?

You can’t enjoy the smell that was in this equipment (a tablet press)! I’m not even sure where to begin with the issues found. Faulty procedures and no supervision were key players here.

Always clean your valves. This was a butterfly valve and what do you think about that black stuff smeared on the steel plate? Can you say “mold”?

Faulty procedures? Yes!

There was a line containing an acid going to this tank. It had a small leak. Fix it? We don’t have time. Resolution – put a paper towel under the leak. It had leaked for years!! The floor below this tank actually had a crater etched out of it due to the slow drip of acid.

And the last one – my favorite. That black area on the pink tablet was found by the customer and sent to the FDA as a complaint! If you cannot see the outline of that picture, it is an insect! How would you like to the be firm investigating this issue?

The Three Sins

You guess it – the common thread of these pictures is woven into the three sins. The Poor Planning, Lax Supervision and Faulty Procedures. As we think on corrective actions with these pictures, we typically focus on “systems” or “facilities”. We think of the Work Force in terms of training. Follow the procedure! Do it right first time! What we miss is truly developing the work force! How to think critically! How to be masterful, valuable and professional!

These pictures are a glimpse into hell – which is not a very nice place to even contemplate…but we must. Otherwise, we don’t see the challenge to avoid them. We miss the opportunities.

I’ll end this article with these warnings. Ignore these three sins at your own peril. Ignore the chance to develop with your work force at your own peril.

Next time, we’ll discuss “where” we fail in more depth.

Thank you for reading my article. If you have any questions, just email me at

#FDA #SinnerorSaint #poorplanning #laxsupervision #GMP