QPs are busy people. The list of QP responsibilities is growing daily and the workload of QPs is ever increasing. QPs are expected to perform to a very high level of quality, almost perfection. The public, regulatory authorities, pharmaceutical companies and patients all put their faith in QPs being the gatekeepers of pharmaceutical product quality, who take personal accountability that the product they release for distribution is safe and effective.

With that level of responsibility and expectations on their shoulders, one would imagine that the QP is superhuman. Yet a QP is a person like any other, doing the best they can. Like any other person, QPs also make mistakes, take wrong decisions and get overwhelmed with the workload, under the pressure of the enormous responsibility and all the balls they have to juggle.

How can we help our QPs and by extension, the QA teams that support the QPs, to make all that work more manageable?

Let's take batch release reviews as an example.

There are so many things to be checked in batch-related documentation, it's very easy to miss or overlook something. To help us remember what to check, we make checklists for QA and QPs. Checklists that seem to get longer and longer.

What about if we rethink the whole concept? Can we automate some or even most of these aspects that are listed in these checklists? Comparing data elements between systems or documents and checking the completion of data entry fields can surely be done by computerised systems?

What about if we critically look at all the aspects that a QP currently checks (using their checklists) and pick out only the aspects that call on the specific knowledge and experience of a QP, which cannot be quantified or written into an algorithm? For example, deliberating the impact of deviations that might indirectly impact product quality; or assessing the downstream impact of a proposed change to an analytical method of a drug substance.

At the same time, perhaps we can ask ourselves if we as QPs are sufficiently critical about all the things we have to check, review, assess, evaluate, approve, etc? I'm not saying that we should put ourselves out of a job (that's not likely to happen) but perhaps we can consider if we're using the systems available to us in the best way? Are there ways that the systems could benefit our processes, which we could make use of by changing the way we work?

Do we know our systems well enough to trust them, so that we feel comfortable about leaving out those checks and trusting the systems?

Personally, I've found it challenging to let go of my long checklists and trust the "new-fangled" computerised systems. The solution that I found was to familiarise myself with the potential and limits of the systems that I work with, getting a better understanding of how the systems are setup and tested, what the failure modes might be as well as the detection of failures if they occur, and most of all, understanding what the data sources are - the "source of truth" that influences subsequent parts of the process.

Checking less and relying more on the systems meant that I've become more involved in setting up the systems, building-in structure and system rules that make it easier for QA and QPs to rely on them, therefore allowing the QPs to focus on the aspects that rely on a QP's judgment, discretion, pragmatism and sometimes even courage. All the human factors that cannot be replicated in an algorithm to be executed by a computerised system.

The reality is that there are not enough QPs to go around. The QPs that we have are overworked and sometimes perhaps a little frustrated at the minutiae that they have to deal with. Perhaps if we rethink and redesign our QA and QP processes, with some QP creativity and pragmatism, we could make QP work more fulfilling and less routine?