Lowest Number of FDA Inspections Since 2008

FDAzilla has reported that the FDA conducted 39,774 inspections for the year ending 2013.

I guess on any given day, there are at least 109 auditing teams running around the world inspecting our GMP-regulated existence.

But it turns out that 39,774 inspections is a 5-year low for the FDA.  As FDAzilla puts it, this is the first time since 2008 that the FDA has dipped under 40,000 inspections per year.

Was it the government shutdown?  Was it the sequester?  Who knows?

As we ramp into prime inspection season (Q1/Q2 are known times when there's a lot of FDA activity), how are you guarding against getting dinged by the FDA?

• Inspect the (FDA) Inspector
• FDAzilla offer for Zymergi blog readers
• Buy 483 documents

ZOOMS 2 - Fastest Way to View Trends

So in addition to biologics manufacturing commentary, it turns out that Zymergi is actually a for-profit business that provides software, consulting and technical support.

For 2014, we're pretty much booked on the technical support side, but I wanted to take some time to talk about our software products.

Our flagship product is ZOOMS, which is an acronym for Zymergi Object-Oriented Metadata Search.  And in 2014 - thanks to Edward Snowden, more people know what metadata is than in 2008 when we started ZOOMS (v1.0)

So why are we interested in searching metadata? Well, let's take a step back. When working the front lines of campaign monitoring and process support, we noticed that viewing trend data (i.e. tag values plotted against time) was the principal component of process understanding. The more trends a person reviewed, the more process knowledge they gained and the more they understood normal from abnormal.

And in all that time, very few people actually learn to speak "Automationese."

"Hey, did you see that weird thing going on with T100.GLOBAL.CLX.AI05.PV?"
- No one ever

In the automation world, everything is a tag. In the Manufacturing Sciences world, everything is about a measurable parameter within the process. So when you listen to the process scientists and engineers talk, it's always about some parameter (e.g. "Optical Density") in some unit (e.g. "Tank 100"). That right there is the metadata of a tag.

The tag takes care of the Y-axis on the trend. What about the X-axis?

The X-axis deals with time-windows: start times and end times and the metadata around the time-windows are called, "batches." Specifically using S88 terminology, people involved with campaign support are interested in Unit Procedures, a.k.a. "unitbatches."

I'll leave the formal definition of "unit procedure" up to the automation gurus, but to a Manufacturing Sciences data engineer, a unit procedure is a process that happens on a piece of process equipment.

So say you're making rituximab in production bioreactor T100 using the version 1.1 process and batch R2D201 ran from 20-Dec-2013 to 28-Dec-2013... that there is a unit procedure:

batchid	unit	product	procedure	start time	end time
R2D201	T100	rituximab	production culture version 1.1	20-Dec-13	28-Dec-13

The metadata around this time-window (i.e 12/20/2013 to 12/28/2013) are as follows:

• R2D201
• T100
• rituximab
• production culture version 1.1

So it stands to reason that if an internet user who knows nothing about a subject can type keywords into Google and get the most relevant results on that subject; that in 2014, a process citizen who doesn't know too much about the process ought to be able to type some keywords into a webpage and get some process trends.

And now they can: Introducing ZOOMS 2:



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Yes, We're Still Alive

Yup, we're still alive around here.  Crazy busy with some exciting things afoot.

Next week, we're at the OSIsoft PI User's Conference 2014 in San Francisco:

So if you're around and want to meet up, come find me @zymergi.