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.

Delegation of Authority Log: Tips for Monitors

We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principal Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.

That’s what makes the Delegation of Authority (DoA) log so important and why regulatory inspectors care about it so much. A DoA log serves as evidence that a PI has assigned study tasks only to those staff members with the education, training, and experience to carry them out. If delegates are unqualified to perform their tasks, subject safety could be at risk and it’s highly likely that the study data would be unusable.

Yes, SOPs Are Hard To Write…It’s Not Just You

Ask anyone who works in a regulated industry about the purpose of SOPs and you’ll be told it has to do with minimizing variation.  Consistency, they’ll say, promotes quality.  It follows, then, that SOPs must be straight-forward and unambiguous.  If procedures are too complex or can be interpreted in a number of ways, they will not produce consistent results, and quality of the end product, whatever it is, will be at risk.  Simple.  Obvious.  SOPs 101.

It’s too bad for us that tasks are not always simple or obvious.  Often, a worker can achieve a quality result only by correctly responding to a number of variables that could arise.  An SOP that outlines such procedures has to describe each situation the worker might encounter and then provide the appropriate corresponding response.  In complicated procedures, these situations can become nested.  (Is it A, B, or C?  If it’s C, is it X, Y, or Z?)  An otherwise simple, linear set of instructions can quickly become a complex decision tree.  Also, the distinction between situations that require different responses may not be clear cut, and may only be a matter of degree.  Unless decision criteria are thoroughly explained, each worker will devise his or her own, and consistency will be lost.  Naturally, the more complicated the instructions, the more subject to misinterpretation they are.  SOP writers are challenged to capture all this complexity in a clear, concise set of procedures.

We expect a lot from our SOPs.  In many companies, SOPs don’t just supplement training, they are training.  Once upon a time, new employees were mentored by seasoned workers who would teach them the rationales behind the procedures and share undocumented nuances that they’d learned over the years.  Now, with mentorship programs becoming an extravagance most companies can no longer afford, we increasingly rely on SOPs to communicate that accumulated wisdom.  We also use SOPs to demonstrate regulatory compliance.  Sometimes, we even expect to use our SOPs as a means of legal defense, should our conduct be called into question.  Is it any surprise that the more we try to cram into our SOPs, and the more masters we have them serve, the harder it is for us to write them in a concise, easy-to-follow manner?

Smaller companies, with minimal or non-existent training staff, may rely more heavily on SOPs than their larger counterparts do, yet maintaining SOPs requires a significant resource commitment of its own.  Subject matter experts are needed to research the latest regulations, determine their impact on existing procedures, and author updates.  It’s difficult for experts in small companies to move steadily through this process because SOP maintenance is necessarily put on the back burner when profit-generating work demands. 

So, if all along you’ve been wondering why writing and revising your set of SOPs seems so hard or takes so long, maybe you can take some comfort from the fact that it’s not just you!

By Laurie Meehan

If you think you might like some help writing or maintaining your SOPs, contact us at info@polarisconsultants.com and we’ll set up some time to talk.