What Suprises GCP Auditors?

Last month, I scheduled one-on-one discussions with our most experienced GCP auditors to ask each of them the same question: What surprises you most about the audits you conduct?

I guess you could say that I was the one who was surprised. I’m not sure exactly what I was expecting to hear, but I thought my teammates were going to talk about things that were new. Instead, I heard a lot more about things that have been around for a long time. To a person, my colleagues said they were surprised to be observing some of the same audit findings they were observing 30 years ago...which *is* surprising when you consider most of them were mere children at the time. ;-)  It seems we have some stubbornly persistent quality and compliance issues in the biopharma industry that decades of neither experience nor technology have seemed to remedy. And the problems are not just persistent; they’re interrelated.

How to Tip Off a GCP Auditor in 25 Words or Less

By Laurie Meehan

“What tipped you off?”  “How did you know to look there?”

When our GCP auditors conduct training and deliver guest lectures, they frequently hear those questions from class attendees.  Sometimes the tip-off is something very subtle that requires the keen eye of an experienced auditor to notice.  And other times, not so much.

The Principal Investigator and Study Coordinator comments below are real; these are conversations our auditors had with site personnel.  Really.  No kidding.  Pinky swear.  The audit findings, not surprisingly, are real too.  I do confess to having taken some liberties with the Auditor Notes and Remediation Recommendations. 

What Does Risk-based Monitoring Mean for QA Auditing?

By now, we all know that risk-based monitoring isn’t just about changing the role of the CRA; it’s transforming the way clinical studies are managed.  So what does that mean for QA teams who audit these new processes?  Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

It’s a slippery subject.  Traditional monitoring relied on the gold standard of on-site visits every 4-8 weeks and 100% SDV.  RBM is not replacing this standard with another.  RBM is a framework for customizing a monitoring approach for each study, and guess what -- “custom” is a lot trickier to audit than “standard.”

Questions All Auditors Should Ask: the Use and Misuse of Audit Checklists

There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all important question: "Why?"  How can you develop the best checklists possible and avoid relying on them too heavily?

On the Quality of Vendor/Supplier Audit Responses

The Compliance Perspectives post this month was written by guest blogger, John Janeri, an independent contractor working with Polaris.

After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.  I’ve done many of these solo audits, and I’ll admit that I've often wondered who at the Sponsor* company would communicate the findings to the Auditee and review their responses.  But no matter, I've completed the contracted assignment and I'm now off doing something else, right?  Not so much anymore.