A pilot study on the quality management system of in-vitro diagnostic reagents.
- Author:
Xin LIU
1
;
Jia-hua HUANG
;
Feng-ling XU
;
Ze WANG
;
Wei-kang GU
Author Information
1. Shanghai Municipal Drug and Medical Device Evaluation Center.
- Publication Type:Journal Article
- MeSH:
China;
Equipment and Supplies;
standards;
Humans;
Indicators and Reagents;
chemistry;
standards;
Pilot Projects;
Quality Assurance, Health Care;
organization & administration;
Quality Control;
Reagent Kits, Diagnostic;
standards;
Safety Management;
Technology, Pharmaceutical;
organization & administration;
standards;
Total Quality Management
- From:
Chinese Journal of Medical Instrumentation
2006;30(3):199-205
- CountryChina
- Language:Chinese
-
Abstract:
This article makes a pilot study on the key points of the quality management system of in-vitro diagnostic reagents by analyzing the technical characteristics and production methods of these products as well as the status in quo, and problems the in-vitro diagnostic reagent industry in China is facing nowadays. It can serve as a reference to the supervision departments and the manufacturers in this field which are establishing and running the quality management system.
