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Everything GMP: My Thoughts On The Current State of GMP After 1 Year In The Industry.

A Blog By Jackson Williams

Hi, my name is Jackson Williams. I joined Phizzle to be at the forefront of data collection and automation because of my passion and educational background in data analytics. I was especially excited after learning how the pharma and life sciences industry had such big gaps between where they currently are and where they need to be in their data collection and automation processes.

Over the past year, I’ve worked extensively with the same instruments used for quality assurance in pharma manufacturing plants and their clean room facilities.

These manufacturers produce life-saving drugs and cutting-edge vaccines that neutralize nasty diseases and illnesses.

This industry constantly realizes the innovations that forty years ago we thought were complete fever dreams that couldn’t actually be done. But even with the insane level of sophistication going into the actual production of medicine.

I was shocked to learn that the IT architectures used to support GMP use cases are at least a decade behind virtually every industry in the world and Cloud-native solutions are rare.  Modern software concepts like software-defined, microservices architectures are not common.  In short, the vast majority of the software tools in biopharma manufacturing, I’ve learned, are architecturally pre-Facebook, pre-AWS, and pre-iphone.

It’s important to note that the culprit isn’t the devices themselves…

Over a few decades, those instruments have taken quantum leaps in overall operability and networking while their sampling accuracy has continued to be refined and perfected. I’m talking about how data is sourced from the instruments to ensure the highest level of data integrity and remain in compliance with regulations like 21 CFR Part 11.

Right now, QA technicians are still physically pressing buttons on the front panel to take samples…

Relying on instrument printouts for results...

Hand-copying sample data…

And manually logging data into their operations database.

These practices might have had a place in the 1990s when data collection and database solutions were not as sophisticated…

But in 2024, it's appalling that these procedures are still in place.

Especially when it comes to the mission-critical operations in pharma when these manufacturers are literally creating life-altering drugs (medicine like Merck’s Keytruda)...

This aspect of the industry is not just due for big changes… It's in desperate need of massive change. I believe the first step in modernizing this very obsolete system is…

Extracting the sample data directly from QA instruments.

This is crucial because it alleviates all the possibility of error that may result from a lab tech hand-copying results and transferring them into their operations database system.

Right now, this only exists for some QA device manufacturers… And their solutions only work for their devices.

Sadly, this largely ignores the fact that big pharma manufacturing plants and their clean rooms don’t use just one manufacturer for all of their hundreds or thousands of QA instruments.

They are using a variety of instruments that fit into their unique GMP’s and SOP’s.

That’s why I’m so excited to be a part of Phizzle and help build its first-to-market solution that extracts data from QA instruments regardless of make, model, or manufacturer.

Standardization in data collection is only the first step of many that will get these industries where they need to be.

These are just my thoughts, but I would love to hear about your experiences in the industry.

You can share what you’re thinking, in the comments section below.

If you’re reading this and you’re currently dealing with outdated data collection processes. You’re looking for a new solution to ensure the highest level of data integrity… And remain in compliance with 21 CFR Part 11…Without disrupting your entire workflow that’s already in place. 

Lastly, I want to thank you for reading this far. There isn't going to be any schedule for this blog. There could be three blog posts in a week and then maybe only one in a month… I’ll only be posting when there is something worthy to be posting about. 

Thank you for reading.   

Until next time,  

Jackson Williams 

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