Good Laboratory Practice

GLP Qualification Procedures

Design Qualification

In order to meet the needs of our customers, Bruker has always committed itself to guaranteeing a continuously high standard in production, service, and support. Bruker's ongoing commitment was reaffirmed in 1994 with the attainment of the ISO9001 certification for its Quality Managment System. All AVANCE spectrometers and magnets fulfill all applicable safety requirements and comply with the CE norms. Hence, Bruker can provide the best evidence and support to Laboratory Managers to meet their requests for Design Qualification.

Installation and Operational Qualification

The introduction of the Automatic Test Procedure or ATP software in 1997 helped to establish a worldwide standard with which instruments and their associated probes are tested. Depending upon the hardware components with which the spectrometer is equipped and depending on the type of probes, a series of precisely defined tests must be executed as part of the IQ process. The test results are stored in a data base giving important statistical information which is in turn fed back into the design and manufacturing process.

The sample screen shown to the right shows a typical screen with the to-do-list for a 5-mm multi-nuclear QNP probe equipped with Z-gradient coil. Without this gradient coil equipment, the number and type of tests would be slightly different. Hence, individual components are tested in the most suitable and informative way.

To further assist our customers with diagnosis of both hardware and software related problems, we introduced the NMR-CHECK program in 1995. It provides an interface for running diagnostic programs. These tests can be run locally by trained on-site personnel as well as remotely by Bruker engineers. More than 50 sites in industry and academics have NMR-CHECK running and we expect the numbers to grow significantly over the next few years. NMR-CHECK is an excellent example of BRUKER's efforts in supporting the customer in the Operational Qualification or OQ process.

Performance Qualification

The Good Laboratory Practice or GLP software package is the final component with which Bruker helps to guarantee consistent spectrometer operation under the highest quality requirements. Well-chosen tests evaluate software and hardware components in a fully automatic manner, covering the setup of the experiments as well as the data acquisition and the printout of the final test report. The tests are similar to the ones that an engineer will run during the installation of the instrument. In fact, some of the evaluation programs are actually used in ATP and GLP.