[Discussion on the key aspects of risk control and problems of quality management systems for allogeneic bone products]

Shaolei Tian

[Discussion on the key aspects of risk control and problems of quality management systems for allogeneic bone products]

Zhongguo Yi Liao Qi Xie Za Zhi. 2012 Sep;36(5):365-9.

[Article in Chinese]

Author

Shaolei Tian¹

Affiliation

¹ Center for Certification of Drug, State Food and Drug Administration of China, Beijing, 100061. sltian1@yahoo.com.cn

PMID: 23289344

Abstract

From the view of the potential risks of allogeneic bone products in clinical use. the key aspects of risk control and quality management for these products are discussed, as well as the general problems existing in the quality management system of their production enterprises in China are briefly introduced.

Publication types

English Abstract

MeSH terms

Bone Transplantation / instrumentation
Bone Transplantation / methods*
Humans
Quality Control
Risk Assessment
Transplantation, Homologous / adverse effects*
Transplantation, Homologous / instrumentation
Transplantation, Homologous / methods*