Norm Howe's blog

The Myth of the Generic SOP

Posted on Mar 24th, 2014 by Norm Howe

How many times has this happened to you?  You have been assigned the task of writing a Standard Operational Procedure (SOP).  When you grimace and explain that you don't have an extra eight hours to spend on it, your boss says "Why can't we just download a generic one off the internet?"

He says this with such naivete that you realize that more discussion is pointless.  You decide to give in and go along.  Big mistake.

Dear FDA, The Inconsistency is Killing Us

Posted on Mar 15th, 2014 by Norm Howe

VariabilityHey FDA, you do a necessary job.  And you’re good at it.  Mostly.

But you could do a lot better.

When you inspect us, you require consistency; rightfully.  You tell us that we have to be consistent in our application of our procedures within an individual site, and between sites.

“When I Go Slow, I Go Fast”

Posted on Mar 9th, 2014 by Norm Howe

Japanese carpenters have this saying. 

American carpenters have a similar saying, “Measure twice, cut once.”  What do these two quotes have to do with a blog about regulatory compliance?  Everything!

Off-Label Use of Medical Devices

Posted on Mar 2nd, 2014 by Norm Howe

When a patient comes into a physician's office, the patient is looking for the best, most modern care they can get.  And a physician certainly wants the same thing.   

This search for the best possible treatment presents a dilemma, however.  When might the best treatment also be a treatment that is still in the process of being developed?  When might a physician's search for the most advanced treatment cross over into medical research, and where does FDA draw the line between the two.  The answer is clear in some cases, but not so clear in others. 

Don’t Automate a Dysfunctional Process 2

Posted on Feb 24th, 2014 by Norm Howe

Last time I told you about the foundry General Manager and his edict to automate.  He had demanded that a robot needed to be installed and operating in the foundry or the Engineering Department would be fired.  If you're thinking about automating anything, you need to see this.  Here is the conclusion of the story:

The General Manager and the Robot (concluded)

Don’t Automate a Dysfunctional Process 1

Posted on Feb 16th, 2014 by Norm Howe

Are you thinking of automating a business process?  If not, you should be or you’re going to get left behind.  But before you do, listen to this true story.  It was told to me many years ago and it occurred many years before that. 

“Oh, forget it Howe!”  I hear you saying.  “Business isn’t the same as it used to be.  Everything’s changed.”

To that I say read on.  You’ll be amazed.  The applications of this tale were valid then; they’re valid now; and they will be valid a hundred years from now.

Why Validate?

Posted on Feb 9th, 2014 by Norm Howe

HawkingStephen Hawking said, “The greatest enemy of knowledge is not ignorance.  It is the illusion of knowledge.”

Was he talking about process validation?  Probably not, but he could have been.  I don’t know how often I’ve been told, “We know this process works.  We’ve been making this product for decades.” 

Symptomatic Solutions: the Slow, Gurgling Death of a Factory

Posted on Jan 26th, 2014 by Norm Howe

root causeWant to lower costs?  Want to reduce the risk of problems with FDA?  Train as many people in your organization as possible to write good Root Cause Analyses.  You will eliminate repeat errors, save prodigious quantities of money, and improve critical thinking skills.

How Do You Tell if a Dietary Supplement Will Work?

Posted on Jan 19th, 2014 by Norm Howe

In my last post I discussed the safety of Dietary Ingredients and Dietary Supplements.  We saw that a company that wants to market a New Dietary Ingredient* must notify FDA 75 days in advance, and in that notification must present information on the safety of the NDI.  The burden is on FDA to prove the NDI is unsafe if it does not deem the information sufficient.

This time I want to tell you about the claims that a Dietary Supplement marketer can make about their product.  Dietary supplement marketers do not need to register their products with FDA or get FDA approval before producing or selling dietary supplements.  They must, however, register their manufacturing facilities with FDA.

The Drugs and Dietary Supplements Dilemma

Posted on Jan 12th, 2014 by Norm Howe

How would you like to have a pill that would reduce body fat, increase muscle mass, and improve glucose tolerance?  Well, you do, if you’re a mouse.  Making a similar product available for people and knowing that it will work?  That’s another story.

Wonder Drug? 

Ursolic Acid, a component of apple peels, increases muscle mass and decreases fat mass when 0.14% of ursolic acid was added to the diet of mice.  In addition, it seems to increase the activity of insulin!  Ursolic acid also increases brown fat, a tissue that shares developmental origins with skeletal muscle.

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