Ever wondered, why automation is so limited in pharma QC?

Liquid handlers are everywhere in pharmaceutical R&D labs, streamlining processes and boosting efficiency. Yet, if you look around a QC lab, you’ll notice something surprising: these powerful tools are rare. Ever wondered why? A quick search for “Liquid Handling” and “GMP” will pull up almost every established liquid handling company, each claiming something about GMP compliance. Yet, despite these claims, genuine GMP-compliant liquid handlers are seldom seen in QC labs. 

So, what’s going on? The reality is that most of these systems aren’t truly GMP-compliant in the way QC labs need. Many companies mention “GMP” in their materials, but often as an add-on, lumped together with standards like IVD (In Vitro Diagnostics). For them, GMP compliance usually means checking a few boxes, like adhering to basic 21 CFR Part 11 requirements. However, GMP in QC environments is much more rigorous, requiring full adherence to standards like GAMP 5—a concept that, for many in the industry, may feel as foreign as a space rocket.

This gap between claims and reality has major consequences for QC labs. Here’s why liquid handlers aren’t more common in GMP-regulated environments:

1. Customization Trumps Standardization

Most liquid handlers are built for standardized workflows that don’t translate well to QC’s diverse needs. These systems are often either kit-based (such as those used in diagnostics). Alternatively, they are highly customized for a specific application. In QC, this means you’re often left with a tool that can handle only one specific type of sample preparation, and if your User Requirements Specification (URS) wasn’t exact, you’re limited. Need to run multiple types of analyses on the same sample? You’ll probably need a separate instrument for each—or more time-consuming customization.

2. The Validation Gauntlet

After a custom system is set up, QC labs face the task of validation—a rigorous process for custom systems that must meet GAMP 5 Category 5 standards. This means extensive application-specific testing and documentation, a process that can easily add one to two years to deployment timelines. Most suppliers lack deep GMP expertise, leaving QC teams to shoulder the entire validation effort, with all the complex, technical hurdles that come along with it.

3. Rigid Systems, Limited Flexibility

The narrow, custom-built nature of these systems makes them inflexible for QC, which typically demands a variety of test types and sample preparation steps. Custom systems become single-purpose tools, restricting their utility and increasing the resources required to manage diverse QC workflows.

In short, while liquid handlers are a staple in R&D labs, they face significant barriers in GMP-regulated QC labs. From lack of true GMP readiness to the burden of GAMP 5 validation, current offerings simply don’t meet QC’s needs. What QC labs need are standardized, GMP-ready solutions that can adapt to diverse workflows without the heavy lift of custom configuration and validation.

Until then, happy validating!