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[Statistical analysis on findings in the quality management system during inspection of IVD manufactures of China].

OBJECTIVE
To explore the current state and the mainly typical problems and vulnerable parts existed in the quality management systems (QMS) of local in vitro diagnostic reagent manufactures.


METHOD
To statistical analyze the problems found in the quality management system of in vitro diagnostic reagent manufactures through inspection organized by CCD, SFDA during the second half year of 2011.


RESULTS
The total level of the QMS of local IVD manufacturers has risen greatly in past recent years, but a lot of problems still existed. The main vulnerable issues existed in QMS of IVD are documentation and recorder control, design control and validation, producing process control, as well as monitoring and quality control etc, to which should be paid more attention in the future improvement made by the enterprises and supervision by the administration authorities.