The GMP qualification as well as the calibration of laboratory instruments and equipment is regulated according to international regulations so that, for example, medical refrigerators reliably fulfil their purpose. After all, there are many limits for medicines, blood reserves, cell cultures, and samples, to which it is very important to comply. To ensure this, a GMP-compliant qualification is carried out. GMP thereby stands for “Good Manufacturing Practice”.
If you order refrigeration and HVAC technology or have it maintained for your laboratory, then it is necessary to obtain a GMP qualification. This involves detailed documentation, measurements, and tests on the relevant equipment.
GMP qualification in detail
In order to fully present the GMP qualification to you, we will guide you through the individual steps. It starts with the design qualification (DQ), in which the design of the equipment including the buildings, premises and auxiliary facilities is checked. tritec® can can support you with this. In the subsequent installation qualification (IQ), you document yourself that the equipment and systems have been delivered and installed in accordance with the previously specified requirements and regulations. On request, we can prepare the documentation for the IQ and make it available to you. Of course, we also offer on-site implementation – this applies to all parts of the qualification.
The next step in the GMP qualification is the operational qualification (OQ). In this part the functions are tested according to the requirements and in compliance with specified limits. This is followed by CQ, which in our case is the calibration. In this process, a documented proof is created in which the reliable work of the critical measuring equipment is ensured in the intended value range while adhering to specified tolerances under current operating conditions. We carry out this calibration in our company by measuring and cross-checking the temperature inside our refrigeration technology, among other things.
Finally, the performance qualification (PQ) follows, in which the previously performed calibration is repeated on site under real conditions. The values determined must not exceed or fall below our specified tolerance for the equipment. If all verifications are fulfilled, the qualification is completed and your equipment is ready for laboratory work. Feel free to contact us if we can (re-) qualify the equipment for you.