It’s that time of the year - the FDA has published its annual BPDR Code update
Luckily for all of us, there is no change to the HCT/P Deviation Codes
Check it out on page 20
That’s it! Whew!
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Read on if you’re not familiar with the BPDR Codes or you’d like a little refresher.
Biological Product Deviation Reporting is applicable to the cellular therapy products that are manufactured. (Note that any adverse reactions to administration of one of those products is reportable through a different system.)
The Biological Products Deviation Reporting Codes apply to three areas of the FDA’s jurisdiction:
Blood BPD Codes
Licensed Non-Blood BPD Codes
HCT/P Deviation Codes
The purpose of the system is to assign a reporting code so that the FDA can categorize all of the things that go wrong throughout the year.
Here’s the main page. Everything you need to know is on this page - the guidance, how to complete the report and then how submit it electronically. The page also has annual summaries - i.e., what other sites are reporting.
There are some nuances to the codes and the reporting. You don’t have to apply a code to all of your deviations, only the deviations that you are reporting to the FDA. You only have to report if that deviation occurred to something that affected a patient, meaning that the biological product had to have been administered or infused to the patient. If you had a deviation on a biological product and you caught it before it got to the patient - you do not need to report it to the FDA.
Let’s work through an example:
Let’s say that during an audit, it was found that a piece of equipment, the centrifuge was not being cleaned prior to use, with the root cause due to ineffective training of a particular staff member. During the course of the investigation, we found that there were thirteen products processed over a month-long period, and then that technologist was rotated to another section. Of those thirteen products, nine had aliquots that were infused back into the patients. We need to report those nine products to the FDA.
Now let’s look at the BPDR Code list.
We can see that there are a number of categories from which to choose -
In our example, we’ll pick EQ for Equipment.
Once we navigate to that section, we will find a few subcategories
We can see that EQ-02-** “Maintenance fits our description, with the further subdivision fitting our deviation exactly.
This is the code that we will use to report all 9 incidents to the FDA.
Of course we will need to show proof of our CAPA and retraining as part of our risk mitigation.
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