GB/T 22275.2-2008

Active

Requirements of conduct for good laboratory practice - Part 2: The role and responsibilities of the study director in GLP studies

良好实验室规范实施要求 第2部分:良好实验室规范研究中项目负责人的任务和职责

Standard Type
GBT
ICS
03.120.20
CCS
A00
Status
Active
Issue Date
2008-08-04
Implementation
2009-04-01
Centralized Committee
国家标准委
Issuing Authority
国家标准委

Application Summary AI generated

This standard specifies the tasks and responsibilities of the study director in Good Laboratory Practice (GLP) studies, ensuring the overall management, technical conduct, and reporting of non-clinical safety tests. It is applied in Chinese laboratories conducting regulated studies for chemical, pharmaceutical, and pesticide product registration, where the study director must oversee compliance with GLP principles. The standard is used to define the study director's role in study planning, data integrity, and final report authorization within testing facilities.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.