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URS in AIQ - how to specify an analytical instrument?

We have covered several parts of the AIQ: a promotion for a couple of fine white papers, DQ, and PQ.

Now let's start to think about how we can best describe our needed analytical instrument, to be able to compare later with the suppliers' proposals.

1. General description, basic GMP requirements

First is first: you want to define what is the actual test you will carry out. Either you can use the pharmacopoeial link for the test, or if you want to be really specific, you can actually describe your method in this document. You should provide the necessary accuracy, precision, or whatever system suitability you need. You don't want to hide what you need, you want to spell it out to the vendors.

2. Data management

If you have a certain requirement regarding data management, be ready to describe it as specifically as you can. This is the point where you can require the connection to LIMS, the automatic processings, etc.

If you are after a computerized system, this is where you can describe your requirements derived from EU GMP Annex 11 and 21 CRF Part 11.

Even if the vendor cannot provide the exact solution you wanted, you can still evaluate the possibilities later, during DQ.

3. Performance requirements

This is where you specify how long and how frequent you are to use the instrument. Durability can be key sometimes when choosing the ideal solution. You want to trust your instrument on a long-term basis, and not to deal with repairs, extraordinary maintenance etc.

4. Infrastructural requirements

This is going to be important later when installing the solution. This part will be the starting point of the DQ when you decide which solution to implement. Do you have enough space? Do you have that kind of air change/UPS/whatever else the solution needs? You need to establish the ground rules, not to pay more on updating the instrastructure than on the solution.

5. Any other requirements

It's not a part of Quality, but since the content of a URS cannot really stop there, you should evaluate all other requirements, like legal, EHS, work safety, you name it.

+1: demo instrument!

Any time you can, ask for a demo! Don't be shy, it's your money, it's your effort. Ask for the instrument, stress-test it with your tests, connect it with your LIMS, involve your QA to evaluate the data flow...this is the best way to go find your solution for your QC.

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