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Design qualification - burden or an effective tool?

Updated: Jun 26, 2023

EU GMP Volume 4 Annex 15 clearly describes the need for design qualification activities. Let me cite the requirement from section 3.1: '[...] DQ where the compliance of the design with GMP should be demonstrated and documented. The requirements of the user requirements specification should be verified during the design qualification.'


So is this only another document to check during an audit, or can QA and also other departments benefit from it?


So let's think about it for a moment. You compiled your URS, evaluated all operational and compliance requirements and you could squeze them all into one document. You checked all vendors, all functional and design specifications so you feel ready to initiate the actual work: to implement! What should you be stopped?


Because most of the times, you as future process owner, are never alone in this. There are a bunch of things to be taken care of, by other departments, by other responsibles.


So intead of another document approved by QA, see this document as a milestone in your project.


It's a bit hard to sum up all useful DQ elements in general (the requirement is there for everything: from a single balance to a new manufacturing plant), but let me try to collect the most fundamental ones:


Fittness for URS

DQ serves as a kind of 'OK' button for the solution planned for the URS. In the frame of this, you evaluate all FS/DS, FAT, compliance certifications or any other documents that prove your URS dreams will get real.

You can also evaluate any additional features you didn't require originally in your URS, and declare if you intend to use it in you GxP environment.


Qualification needs

DQ also helps you to overview what kind of qualification you will need. What to do at which step (IQ/OQ/PQ), and who should do it. If you plan to purchase a qualification package from the vendor, you should evaluate it at this point.

In some cases (like GAMP 4 or 5 computerized systems), the easiest way to deal with this is to build up the traceability matrix, and make it approved along with your DQ.

Here you can also describe the sequence of the qualification steps, e.g., do you need to have your IQ approved before initiating OQ activities.


Vendor/service provider evaluation

You need to declare if your vendor or service provider can act on the level you require, not only when installing and qualifying your system, but also later when you need them to maintain, repair, requalify, etc. This is also not only a paper-activity: the best is to be sure you can trust your service provider, you don't want to get stuck with a non-professional company when you need professional help.

But formally, you should evaluate the vendor's quality management system (in case of critical systems, even with an audit), and you may also need to establish quality (or any other formal) agreement with them.


Any other activities to be done

This is where the cooperation with other departments is key. You need to go through all the needed infrastructure, wiring, connection to other systems, and identify who will take care of it. As I see, this is the point where DQ acts more like a project management tool: all the participants will know what to do.


To sum up, DQ can be a real asset in your hands, if you use it thouroughly, and can help your implementation phase like a charm.

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