This popular blog has been updated in 2022 with the latest FDA data.
As we all know there has been an increasing regulatory emphasis on the importance of Quality Metrics. Where there is a demand, there will also follow a supply and just in time, QikSolve have updated their free tool that scrapes data from various websites and databases and provides a way to trend, track, report and visualise all FDA 483 inspection citations from 2008 all the way up until the end of 2022. In this blog we will demonstrate the use of this tool to analyse the FDA citation data.
This large-scale accumulation of phenomenal amounts of information or “Big Data,” allows for the collection and pooling of structured and unstructured data from normally disconnected sources and facilitates the analysis of trends which would not have been easy to detect via the old manual process. In this particular example, it is the pooling of individual FDA citations across the years into distinct and measurable categories. This “Big Data” analysis is one of the core facets of Industry 4.0, or as it’s specifically known in our industry: Pharma 4.0.
The usual method to find information is to trawl through pages of reports in order to painfully extract data of interest, whereas this tool allows us to coalesce a large body of information into an easily accessible and digestible display (as can be seen in Image 1).
This form of visual analytics is data presented in an intelligent form and allows you to make business decisions based on the hard evidence instead of mere guesswork. Also known as ‘Data Driven Business,’ it is another huge component of Pharma 4.0.
A lot of the technologies springing up in the Pharma 4.0 space follow along this metrics pathway. If you can imagine a data tracker similar to ours, only configured and customised for your individual company, it would allow you to track individual trends, problems or deviations within your facility and make it easier to address them early on instead of getting caught out by an official auditor!
Using this FDA tracker as an example, we could look at the top FDA 483 citations / trends for 2017, the 2020 trends are also available:
From the third page of the table it is clear to see that between 2016 and 2017 there was a 16% increase in the number of FDA 483 citations handed out for CAPAs (Image 2).
This is followed by and 8% increase in the number of citations handed out for Design Controls (Image 3):
However, that isn’t the limit of the tool. Imagine if you wanted to more closely examine the citations for Subpart F- Production and Process Controls which went up 1% between 2016-2017 (Image 4):
Going further into the Production and Process Controls category you can see that the top offender is Written procedures and deviations (Image 5):
Not only that, but moving to the 3rd page of the metrics display allows even more detail from that section to be visualised – in this case, the number and class of the citations handed out within the Production and Process Control category (Image 6):
In Image 7, you can see that in 2017 there were 91 FDA 483 citations handed out for 21 CFR 211.100(a) non-compliance – “There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to posses”:
Just from these images alone it becomes apparent very quickly that if this kind of technology were applied to a normal facility, you would be able to trend and visualise large amounts of data from different sources in an instant. You would be able to keep better track of: environmental monitoring trends, deviations and non-conformances, quality matrices, customer complaints, batch release, etc., the list is endless!
If you are interested in Industry 4.0 or Pharma 4.0, join us on the Pharma 4.0 LinkedIn Group.
For more examples of the technologies that are available, Microsoft offers PowerBI with a AI or machine learning “included.” It’s hard to explain but fortunately a video will help!