In the pharmaceutical industry, many laboratories have always carried out device tests in varying degrees. Mostly, the device manufacturer's instructions or routines anchored in the device software were used. However, it is advisable to define a uniform qualification concept and to provide structured and traceable documentation.
Device qualification, also called system qualification: As part of the qualification of equipment and systems is checked whether the device with the technology used for the intended task is suitable and working properly. In pharmaceutical analysis qualifications are standard for working in compliance with GMP guidelines. The implementation must be laid down in written procedural and work instructions, SOPs. The SOPs should explain all processes in a clear and structured manner and, where possible, resort to risk-based approaches.
To ensure correct analysis and product results, device qualification is enormously important. The regulatory authorities attach increasing importance to this area. Thus, the manufacturers of devices are forced to make substantial contributions to the individual steps.
Design Qualification (DQ) defines the functional and operational specifications of the device. The requirements may not be forgotten from registration documents. Based on this, the corresponding offers will be obtained. By comparing your own requirements (URS User Requirement Specification, specifications) you can already decide here whether the device to be procured will be a good or bad choice. Many companies already carry out risk analyzes in the DQ phase, which then also feed into the following phases: DQ, IQ, etc.;
The DQ is in a condition of incompletion until a purchase decision is made. However, often serves as an advance selection of suitable suppliers.
There may well be situations in which a supplier audit is recommended, for example, when complex or very specific issues are required, and a related development effort is necessary.
DQ should always be made by the user. As a source of information always existing documentation of individual manufacturers can be used, but moreover it is imperative to define your own requirements exactly.
The IQ documents that the delivered device complies constructively with the specifications of the order.
The device will be installed according to a pre-defined IQ plan and each step will be documented. The specifications for the IQ can be standardized very well, since normally all laboratory devices follow a certain sequence. It is advisable to arrange the documents in advance with the buyer in order to take account of in-house control parameters.
The following criteria are clarified at an IQ:
As part of the Operational Qualification, proof is provided that a device works in the selected work environment according to the User Requirement Specification (URS or RS) / specifications. If the device is to be used for many different applications, the cost of testing can be very extensive. In order to keep this effort as low as possible, the documentation must be coordinated with the user in advance. If necessary, a Factory Acceptance Test (FAT) can be additionally demanded and implemented for a smooth OQ implementation. As a result, calibration intervals, maintenance and cleaning instructions are also discussed in the OQ and later specified in a maintenance qualification. In the OQ you should also consider whether a minimum requirement of critical spare parts is kept in stock.
Within the PQ, the documented proof is provided by the user in accordance with the specifications of a PQ plan that the required services for a defined task are provided by the device under real conditions. In the case of complex devices, the concept of system suitability is often synonymously used, while in simple laboratory devices such tests can be omitted, and the qualification is generally completed with the successful completion of the OQ. The frequency of testing depends not only on the stability of the equipment, but also on all components of the system that can influence the analysis results. 1. Defining the performance criteria and test methods. 2. Determine the critical parameters. 3. Defining the test areas. 4. Release of the device for laboratory use. Within the scope of the PQ, it may be necessary to carry out a computer validation. This is however carried out separately. Ideally, the software developer / manufacturer certifies a validation. The software should be delivered and installed correctly (IQ), critical functions were tested (OQ) and the computer-controlled system works as expected (PQ).