DB32/T 3544-2019 Active Jiangsu ProvinceLocal standards

DB32/T 3544-2019 Quality control management specifications for clinical-grade human tissue-derived mesenchymal stem cells

Publish Date: 2019-02-28 Implement Date: 2019-03-30 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 42

Basic Information

Standard Code: DB32/T 3544-2019

Standard Type: Local standards

Standard Status: Active

is_force_gb: no

CCS Name: Basic standards and general methods

ICS Name: Biology, botany, and zoology

Publish Date: 2019-02-28

Implement Date: 2019-03-30

Pages: 20 pages

Scope

This standard specifies the basic requirements, operating procedures, and quality control for the preparation of clinical-grade human tissue-derived mesenchymal stem cells. This standard applies to the sample collection, preparation, cryopreservation, thawing, and quality control of clinical-grade human tissue-derived mesenchymal stem cells.

Development Information

Word Count: 30 Thousand words Pages: 20 pages

Referenced Standards

GB 3095-1996 Ambient air quality standard GB 19489-2008 Laboratories—General requirements for biosafety GB 50073-2013 Code for design of clean room T11/CSSCR 001-2017 实验室生物安全手册(WHO第三版) 中华人民共和国药典三部(2015年版) 药品生产质量管理规范(2010年修订)(卫生部令第79号) 中国药品检验标准操作规程(2010年版) 干细胞制剂质量控制及临床前研究指导原则(试行)(国卫办科教发〔2015〕46号) GB 50346-2011 Technical Code for the Construction of Biosafety Laboratories (with Explanation of the Provisions) GB 50591-2010 Code for construction and acceptance of cleanroom