Interview: Quality First!

Biopharma offers a field of many potential obstacles and pitfalls. One of them is without a doubt the topic around Qualification, Validation & GMP-Compliance.
Elisabeth Haas-Karagiannidis, Head of Quality Management and Validation at Single Use Support, has given some insights in the course of Single Use Support’s podcast series.

Qualification and Validation – why is it such a big issue?

Demonstrating that the equipment is suitable for its intended use by qualification & validation is a mandatory requirement for pharmaceutical industry by authorities. Depending on complexity of systems and risk for product, it can mean a lot of effort. Companies often underestimate the workload accompanied with qualification and end up exceeding project due dates.

How does such a qualification & validation process look like in theory?

It starts with defining the specific requirements of the equipment of interest. The customer needs to define for example on materials and surfaces, and for systems with software on electronic records and data integrity. Also, with regards to regulatory requirements this needs to be considered. Once the requirements are specified in detail and the functional design is agreed on, the machine can be built.
Once built, it is all about testing. Testing is based on the specifications set in design phase. The extent of testing and the assignment to a testing phase is to be done by a risk-based approach, which emphasizes the focus on critical potential threats.

It is common practice that engineering companies offer a basic testing approach, the so-called FAT and SAT. But why has SUS decided to offer services beyond that?

The reason is simply that we want to offer end-to-end solutions. Let me explain: FAT and SAT [factory & site acceptance test] are mainly focusing on critical technical and mechanical aspects, so what we as a manufacturer need to make sure that our product works properly. But the pharma companies need more, in order to finally release the equipment for operational use in a GMP environment. There is additional testing required to verify for example customer-specific configurations, and performance related to a customer-specific process, or tests related to 21 CFR part 11 compliance.
In a nutshell, we do not want to leave our customer alone half-way, we offer the full carefree package from purchase order to release for operations and beyond.

According to your experience, what services are required from your current customers with regards to qualification/validation?

Our customers appreciate very much the services we offer beyond standard testing. We are able to adapt testing procedures to meet the customer’s needs, for example verification runs tailored to verify their specific manufacturing process, which makes qualification and validation services really fully leverageable, meaning that the customer does not need to do further testing internally. I would even name it “next-level leveraging”.

When a customer obtains technologies by Single Use Support, would it also be possible to outsource the whole qualification/validation?

Sure, no worries! It is possible to rely on our experience and let us deliver the whole package. The customer can benefit from the experience of our product experts and additionally make sure that timelines are met for sure.

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