GB/T 22277-2008

Active

Advisory document for good laboratory practice - The role and responsibilities of the sponsor in the application of the principles of GLP

良好实验室规范建议性文件在良好实验室规范原则的应用中委托方的任务和职责

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 provides guidance on the specific tasks and responsibilities of a sponsor (the entity commissioning or funding a study) when applying Good Laboratory Practice (GLP) principles. It is applied in non-clinical safety testing of chemicals, pharmaceuticals, and agrochemicals, ensuring sponsors understand their obligations in study planning, monitoring, and data integrity. The document serves as an advisory reference for contract research organizations and regulatory compliance in China.

Related Standards

GB/T 2828.1-2012 Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection GB/T 19000-2008/ISO 9000:2005 Quality management systems - Fundamentals and vocabulary GB/T 19004-2011 Managing for the sustained success of an organization — Quality management approach GB/T 19011-2013 Guidelines for auditing management systems GB/T 2828.1-2003 Sampling procedures for inspection by attributes--Part 1: Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 19022-2003 Measurement management systems--Requirements for measurement processes and measuring equipment GB/T 6379.1-2004 Accuracy(trueness and precision)of measurement methods and results--Part 1:General principles and definitions GB/T 6379.2-2004 Accuracy(trueness and precision)of measurement methods and results--Part 2:Basic method for the determination of repeatability and reproducibility of a standard measurement method

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.