Researching Combination Product Enforcement

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Researching Combination Product Enforcement

By |2019-04-25T10:30:23-05:00April 25th, 2019|Biopharma / Pharma, FDA, FDAzilla, Medical Devices|

When it comes to scanning 483 observations, can a 15-second search replace hours (or weeks) of research and still provide enough data?

Yes, and more.

Using AI technology and human expertise, the process of researching enforcement and observation trends has become efficient and effective.

The Old Way of Researching Combination Products

Before the introduction of combination products to the Govzilla platform, trying to gather this information was difficult, to say the least.

Most people would start by handpicking a couple of companies that they know have combination products. And then they would:

  1. Search the company
  2. Review all of their 483s
  3. Create the list of keywords and synonyms for the term they’re looking for
  4. Use the list to pick out relevant combo product observations

We asked one Govzilla user, a Director of Quality from a major pharmaceutical company, about how they did this, “It was a very long process. Usually, that could be my activity for half of my day, easily. And if I want to be really comprehensive it would take me weeks. I chose the approach to pick out a couple of representative companies and observations. It’s quite cumbersome and certainly not comprehensive. And after a while your eyes become blurry.”

Fortunately for a lot of other professionals like this Govzilla user, they do not have to do this very often—maybe once or twice a year.

However, moving forward, with more companies launching a lot of new products in the combination product space, they are being asked to look into more specific details and with more frequency.

In those cases, it would be very difficult to find this information doing it the old way.

The New Way of Researching Combination Products

And that brings us to a new, better way of researching and reporting on combination products.

To demonstrate, using the Govzilla platform, let’s create a 483 report by specific keyword, “Combo Product” over the last 5 years.

Out of 6,735 retyped and keyword-tagged 483s in our database, we currently have 102 with combination product observations and this number is constantly growing.

In this chart, you can see the keyword trends mapped out with the top 3 being:

  1. Nasal Spray
  2. Infusion Pumps
  3. Filled Syringe

Note: You can add additional keywords if the ones you need are missing.

Combo Product 1

Next, you can drill down into the inspection details and sort by Site Name, Citations, Keywords, and more:

Combo Product 2

So, much easier, right? If you would like to see this full report, please schedule a demo and ask to see the Combo Product Macro Trend Report. One of our team members will be more than happy to walk you through it.

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Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspectorProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at sales@fdazilla.com.

About the Author

Michael de la Torre

Michael de la Torre is the CEO of FDAzilla.

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