Why Not Totally Awesome Manufacturing Practices?

Why do we say GOOD Manufacturing Practices?  Why not Perfect Manufacturing Practices?  Do we want our drugs and medical devices to be anything less than perfect?  Why not at least Great Manufacturing Practices?  How about this?  Why not Totally Awesome Manufacturing Practices. 

Ok, that’s not going to happen.  But the question still needs to be answered.  Why did FDA call their regulations for manufacturing operations GOOD Manufacturing Practices? There must have been a reason for it with all the other choices available.

I haven’t seen any explanation from FDA.  If you have, please let me know.  I’m going to give you my two cents worth.  Does it represent FDA’s official line?  I don’t know.  But I guarantee you it will be instructive.

We must first understand how GMPs came about.  Each time a new set of GMPs has been promulgated they have been in response to serious problems discovered in the real world.  GMPs have in all cases been drawn from companies who had been using them in every-day production to prevent those problems from occurring in their own operations.

So, GMPs are not theoretical niceties dreamed up by some bureaucrat.  Rather they are practical solutions that are known to work.  GMPs are meant to be used by real people, aging equipment, and competitive business pressures.

GMPs must work under these conditions because they represent everyday life in a drug or medical device plant.  There are no excuses for shipping off-spec product.  A company’s quality system has to work even when its A-team is on the bench, even when equipment gets old, and even under the harshest business competition. In other words, your quality system has to work perfectly all the time, not just when things are going well.

Of course any single practice that must operate with human beings will be imperfect.  When you work with well used equipment, unpredictable failures will happen during production.  Competitive business pressures will cause human beings to take shortcuts.  You simply cannot expect that any procedure that is written and executed by human beings will deliver perfect results. 

So, the best you can hope for when you’re writing an SOP is that the outcome will be good.  Don’t expect perfection.  You’ll be disappointed and end up living a wretched life. 

Given that fact, how do you construct a perfect quality system out of parts that are imperfect?

The answer is redundancy.  GMPs are a belt AND suspenders system.  They consist of layers of protection.  An individual procedure can fail, but the redundancy in a properly constructed quality system will ensure that the failure is detected and corrected before bad product gets to patients.

What, then, is the message to those of us who are tasked with writing SOPs and creating quality systems in the messy environment of daily production?  The answer is that whenever you write an SOP, keep in mind that that SOP will not exist in a vacuum.  It must integrate into your entire quality system. 

You might decide to write the perfect SOP.  But even if you did, it will not be executed perfectly.  Don’t spend excessive time trying to write the perfect SOP.  Instead, write a good SOP, then move on to the next one.

Aim to create a system of good SOPs that together form an integrated quality system that is virtually perfect.