The Standardization Construction And Practice Of Clinical Pathology In Drug Safety Evaluation

As the clinical pathological data can play a vital role in reflecting the frameworkfor the three core principals of a high quality drug safety evaluation center-scientificexcellence, GLP (Good Laboratory Practice) compliance and good animal healthstandards, it is of greatest importance that the gap must be bridged over the currentstatus of the clinical pathological studies of ours with the international standard. Withthe progress of the GLP capability construction in the National Beijing center for drugsafety evaluation and research, endeavors were made in the purchase of newequipments, the qualification progress, the standard operation procedures, thebackground data for laboratory animals, and many other aspects in the clinicalpathological studies.The hardware in the equipment aspect is the foundation for the capabilityconstruction of the clinical pathology. Thanks for the National key program on thescientific development of new drugs our purchased many equipments guided by theprinciples of GLP regulations of OECD and FDA. It made our lab of clinicalpathology meet the needs for the toxicological studies on the chemicals, traditionalChinese Medicines, as well as biotechnology drugs.In the sametime, the software capability construction, the system managementof the purchases, installs, uses,trainning, maintenance, SOP writing of the equipmentshas been established. Furthermore, the metrology, intermediate checks and thequalification of the instruments has been executed. The major analytical apparatusesas Hitachi7180biochemetry analyser, the Sysmex XT-2000iv hematology analyser,the immunization analyser and the Real-time PCR, were carried the completequalifications, as well as the annual performance qualification, which guaranteed thegood condition of the instruments and the accurancy of determination.Guided by the ISO15189and the ISO17025, we built up the clinical pathology group management system, personnel's mission and tranning system, quality controlsystem, and the whole process quality control of the determination of the samples.Experiences gotten from which will be of some help in the internationalizationprocess of the chinese GLP centers.The adoption of the Laboratory Information Management System(LIMS)is oneof the key measures that can be sure of the efficiency on the collection, the accurancy,the intergrity and the completeness of all data generated. The Easy GLP system isbuilt which is based on the MySQL4.0.26databases. We played our part in theclinical pathology by carrying on the installation, operation and performancequalifications to the Easy GLP System and making the data comparison with the rawdata and the electric data recorded by the Easy GLP System. The result showed thatthe system was good enough at the aspects of installation, the menu operation, thefriendly interface, the different legal power and the accessability by over100simultaneous operators. The results of the data comparison showed that the datacollected by the Easy GLP System were consistent with the raw data and the statisticsdata were almost in consistency with those by the SAS program. All results showedthat the Easy GLP System can assure the credibility of the data, the authority of thestatistics results, the periodical backup of the data and the upgradation of the workefficiency, above everything else, the Easy GLP System regulation matched the21CFR Part11of USFDA.The establishment of the background data for the laboratory animals is one of theimportant preconditions in the standardization process of the clinical pathologylaboratory. We took all the clinical pathology indexes of the SD rats, the Beagle dogsand the Rhesus monkeys accumulated in the last2years. All the data were analyzedin different ages and sexes and the reference values of the clinical pathology indexeswere constructed, which will play an important role in the mutual acceptance of datain clinical pathology.All the researches showed that this laboratory is being carried on strengtheningand raising in accordance with the international GLP regulations and guidelines in thehardware and software. The clinical pathology has finished the basic standardization construction. It can help the standardization construction of the GLP facility andprovides some experince in the laboratory of clinical pathology in China.