What is meant by URS, DQ, IQ, OQ and PQ?
Taking a project for the planning and introduction of GMP IT systems as an example, qualification is performed in the following steps:
URS: For the installation of IT systems in a cleanroom, a URS (User Requirement Specification) is created at the start of the project. In this, the customer defines the GMP-critical parameters - including those for the IT systems if applicable.
DQ: DQ (Design Qualification) is performed on the basis of the URS. This checks whether the hardware quotations received satisfy the requirements stipulated in the URS. Following test procedures and risk analysis, a successful DQ process results in a purchasing contract with the chosen supplier.
HW IQ: Once the IT hardware ordered has been supplied and installed, the next step is HW IQ (Hardware Installation Qualification). The purpose of this is to compare the hardware supplied to the hardware ordered. It checks whether all the requirements defined in the URS and the specification have actually been fulfilled.
The functions of the hardware are also tested and documented in detail as part of HW IQ. This includes the connection of a scanner and correct functioning of the input hardware (keyboard, touchscreen, etc.), for example.
OQ / PQ: Subsequent OQ (Operational Qualification) and PQ (Performance Qualification) then involve checking the IT system with the software to be run on it and in conjunction with the overall system process controlled by this.
Tip 1: Incorporation of GMP requirements from the outset
At the start, it is often difficult to exactly assess the requirements involved in a qualification process for IT systems for use in cleanrooms. Incorporation of the GMP requirements for IT when creating the URS can significantly simplify the qualification process as a whole. Because knowledge of the GMP-critical parameters at an early stage is essential to be able to select IT systems that are suitable for cleanrooms.
Tip 2: Only consider suppliers of GMP-compatible hardware
Risk analysis has to be performed as part of the hardware DQ process before deciding on a supplier. Narrowing down the number of possible suppliers to those who can deliver GMP-compatible hardware saves time. The GMP compliant configuration and design of the hardware can minimize or even exclude potential risks. This makes it easier for responsible pharmaceutical manufacturers to assess the risks involved.
Tip 3: Get help with hardware IQ
Following installation and prior to operation, the IT hardware has to undergo a hardware IQ process for GMP system qualification. The first step in HW IQ is to produce a hardware design specification. Based on the systems ordered and supplied, this involves the creation of a test protocol as a template for each device type on the basis of a stipulated test specification.
All documents have to be checked employing the four-eyes principle before and after hardware IQ. Depending on the magnitude of the project, this can give rise to a very extensive overall procedure, as all functions such as correct installation, configuration and communication with peripheral devices have to be checked and documented in the test protocols.
Particularly if time is a critical factor in a project, and parallel processes are necessary, it may well be worth calling in an experienced service provider to carry out hardware IQ. The client can then rely on the service provider to produce the documents and check them before and after HW IQ. The client is only responsible for the actual checking procedure. The vast amount of coordination and documentation work is reduced.
How can we help you?
We would be pleased to assist you with your project from start to finish. Not only can we promise to supply you with guaranteed cleanroom-compatible IT systems that will considerably simplify the qualification procedure, our quality management team would also be pleased to help if you would like support when creating the URS and performing hardware IQ. All our platforms come with full documentation on usage in a GMP environment to make it easier to assess the risks. We can also provide assistance with any necessary re-qualification processes or IQ maintenance as part of HW IQ, as well as with hardware upgrading or hardware retrofitting.
You can also find out more about this topic in our presentation "Hardware Installation Qualification (HW IQ) for IT Systems in Cleanrooms" and at booth B2.9 at the Lounges trade show, taking place in Karlsruhe between 5 and 7 February 2019.