Invisible Ink in GLP and GCP Research
I believe we’ve stepped off the trail to data integrity and that we’ve been lost for a while now.
It’s time to stop, take our bearings, and see if we can work toward agreement on where the trail to data integrity is.
It’s my hope that this post will help start a much needed conversation, which can be continued back home at your companies and with your service providers.
There was a quip that Part 58 only requires data to be recorded in ink, and it will be interesting to see how the use of invisible ink is a problem. And you’re right – when you use invisible ink, there’s a way to reveal what was written. However, in the case studies we’ll discuss today, there is no way to reveal what was written – it’s as if the data were never recorded at all.
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When You’re Lost On The Trail, Stop!
Let’s start by stopping and taking a look at recent FDA enforcement in the GMPs.
In addition to their efforts to protect us from unsanitary manufacturing conditions at compounding pharmacies, they’ve really upped their game looking for data integrity problems in the manufacturing processes for both active pharmaceutical ingredients and finished pharmaceuticals.
We’ve seen a number of important data integrity Warning Letters over the past few years, and back in 2014, FDA issued a helpful set of FAQs on the GMPs.
For example, FDA has communicated that electronic chromatography records supporting GMP work must be maintained rather than relying exclusively on printed “copies” of chromatograms.
Why? Because printed “copies” of chromatograms are not sufficient.
Printed copies typically don’t include attributes like “the injection sequence, instrument method, integration method, or the audit trail, of which all were used to create the chromatogram or are associated with its validity.”
What does this mean for us?
After You Stop, Take Your Bearings
I’m not a GMP practitioner, so let’s come back to the GLPs and GCPs.
Some of you don’t have experience working outside of a quality or compliance group performing GLP or GCP regulated activities. I’m going to share a little history with you in the hopes it gives you some new insights into how we got where we are today…
Next up, click here for a “GLP/GCP History” crash course + 2 case studies…
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