GB/T 39766-2021 in English

VALID

Management specification for human biobank

Issued on:2021-03-09
Implemented on:2021-10-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $310.00
$301.00

Standard No:	GB/T 39766-2021
Document status:	VALID
Title in English:	Management specification for human biobank
Title in Chinese:	人类生物样本库管理规范
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2021-03-09
Implemented on:	2021-10-01
ICS Classification:	07.080-Biology. Botany. Zoology
Chinese Classification:	C40-Medical optical instrument and endoscope
Professional Classification:	GB-National Standard
Related Keywords:	management specification three-tier management structure management responsibilities genetic resource management facility classification appendix a human biobank introduction standard framework
Related Topics:	biological sample sample Cooler Biospotter library sampler sample standard human being biological sampler paraffin sample biological sample paraffin sample sample system Biospotter sample device test tube sample sampler library+ biological sample preparation biology human species run the sample class biological samples long-term biological sample gold Overseas Biobank biobank Create a sample GBT39766 GB/T 39766-2021 Biobank SNAS recommendations Biological sample GCP Sample library specification group label Sample library The road to standardization of biobanks National standard classification of biological samples for biotechnology Sample category management Standardization of biological resource sample library Consumables and reagents Standard biological samples

《GB/T 39766-2021人类生物样本库管理规范》由TC559（全国生物样本标准化技术委员会）归口，主管部门为国家标准化管理委员会。

Introduction

Standard Framework and Technological Evolution

Dimension	GB/T39766-2021	International Standard ISOTC276	Difference Analysis
Ethical Requirements	Integration of GB/T38736-2020	Refer to the Helsinki Declaration	Domestic standards place more emphasis on genetic resource management
Facility Classification	Appendix A clarifies functional zoning	Divided by biosafety level	Clearer operation process orientation
Traceability system	Article 10.2.11 Mandatory traceability	Recommended traceability requirements	Domestic traceability nodes are more refined

Analysis of core clauses

5.2 Organizational structure requirements

The standard clearly requires the establishment of a three-tier management structure: management (decision-making), science and technology committee (academic evaluation), and ethics committee (compliance supervision). Among them:

Management responsibilities need to cover the establishment of a quality system (Clause 5.2.1c) and the formulation of a confidentiality system (Clause 5.2.1h)
The executive body must be set up independently and report directly to the management (Clause 5.2.4)

7.3 Key indicators of facility environment

Typical case: During the renovation of the sample library of a tertiary hospital in Shanghai, by:

Installation of an oxygen monitoring system (Clause 7.5.3)
Adoption of anti-slip and anti-freeze flooring (Clause 7.2.2)
Configuration of dual circuit power supply (Clause 7.7.2)

The liquid nitrogen storage area is fully compliant with the requirements of A.3.1 No heat source area.

Implementation Suggestions

Informatization Construction Path

According to the requirements of Clause 10.2.12, it is recommended to implement it in stages:

Stage	Construction Content	Compliance Points
Basic Period	Sample Full Process Tracking System	Meet the Traceability Requirements of Clause 10.2.11
Development Period	Interconnection with HIS System	Comply with the Transmission Encryption Specification of Clause 10.3.2

Staff Training Program

According to Clause 6.4, it is recommended to adopt:

Pre-job certification: includes modules such as biosafety (Article 7.1.4), equipment operation (Article 8.3.3), etc.
Annual refresher training: focuses on updating knowledge of ethical standards (Article 5.2.3) and emergency response (Article 8.1.4)

More samples: JJG 21-2008 QC/T 942-2021 YD/T 3934-2021

Sample only — not a preview of GB/T 39766-2021